Name (Synonyms) | Correlation | |
---|---|---|
drug2396 | Suspension of heat killed (autoclaved) Mycobacterium w Wiki | 0.16 |
drug2334 | Standard protein group Wiki | 0.14 |
drug1948 | Pulmonary and Motor Rehabilitation Wiki | 0.14 |
drug607 | Collection of blood samples in order to create a biocollection Wiki | 0.14 |
drug468 | COVID-19 and Intensive Care Wiki | 0.14 |
drug224 | Assessment of Dietary Changes in Adults in the Quarantine Wiki | 0.14 |
drug404 | Brief educational video Wiki | 0.14 |
drug938 | File Scanning Wiki | 0.14 |
drug1670 | Observational study Wiki | 0.14 |
drug2515 | Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki | 0.14 |
drug1145 | ICU treatment Wiki | 0.14 |
drug125 | Admission to ICU for COVID-19 Wiki | 0.14 |
drug1085 | Hydroxychloroquin with Azithromycin Wiki | 0.14 |
drug2990 | risk factors Wiki | 0.14 |
drug440 | CNS magnetic resonance imaging (MRI) imaging Wiki | 0.14 |
drug1193 | Individualised Ayurveda Wiki | 0.14 |
drug903 | Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Wiki | 0.14 |
drug1926 | Propranolol Hydrochloride Wiki | 0.14 |
drug30 | 2: Standard of care Wiki | 0.14 |
drug2800 | demographic and clinical data obtained from hospital's electronic medical record. Wiki | 0.14 |
drug690 | Current care per UCLA treating physicians Wiki | 0.14 |
drug2893 | miniprobe Alveoflex Wiki | 0.14 |
drug1969 | Quality of Life Wiki | 0.14 |
drug291 | BIIB091 Wiki | 0.14 |
drug723 | Data collection from lumbar puncture Wiki | 0.14 |
drug1187 | Impact Event Score Wiki | 0.14 |
drug859 | Enoxaparin sodium Wiki | 0.14 |
drug18 | 1: Naproxen Wiki | 0.14 |
drug962 | Fondapariniux Wiki | 0.14 |
drug1144 | ICU Recovery + Physical Therapy Wiki | 0.14 |
drug2588 | Umbilical Cord Mesenchymal Stem Cells Wiki | 0.14 |
drug797 | Duplex ultrasound and Computed Tomography Angiography Wiki | 0.14 |
drug1874 | Point of care ultrasound Wiki | 0.14 |
drug850 | Enhanced Usual Care Wiki | 0.14 |
drug1072 | Hospital anxiety and depression scale Wiki | 0.14 |
drug1261 | Isoflurane Inhalant Product Wiki | 0.14 |
drug1341 | LifeSignals Biosensor 1AX* Wiki | 0.14 |
drug814 | EMPOWER Wiki | 0.14 |
drug2647 | Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic Wiki | 0.14 |
drug210 | Argatroban Wiki | 0.14 |
drug1655 | Nutrition support Wiki | 0.14 |
drug675 | Covid ICU containment measures Wiki | 0.14 |
drug2343 | Standard therapy of COVID-19 Wiki | 0.14 |
drug357 | Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT) Wiki | 0.14 |
drug2249 | Sevoflurane inhalant product Wiki | 0.14 |
drug92 | AV-COVID-19 Wiki | 0.14 |
drug722 | Data collection from blood draw Wiki | 0.14 |
drug2768 | blood sampling for biobank Wiki | 0.14 |
drug2074 | Replenish protein group Wiki | 0.14 |
drug1489 | Microscopy of defined brain regions on autopsy specimens Wiki | 0.14 |
drug2513 | Thrombin Generation Assay (TGA) Wiki | 0.14 |
drug1909 | Primary care professionals reports of potential patient safety incidents, non-COVID-19 related Wiki | 0.14 |
drug488 | COVID19 Wiki | 0.14 |
drug1817 | Physiotherapy Wiki | 0.10 |
drug1022 | HB-adMSCs Wiki | 0.10 |
drug2595 | Unfractionated heparin Wiki | 0.10 |
drug960 | Follow up Wiki | 0.10 |
drug2263 | Simvastatin Wiki | 0.10 |
drug269 | Azithromycin Tablets Wiki | 0.10 |
drug217 | Aspirin Wiki | 0.10 |
drug1930 | Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health Wiki | 0.08 |
drug603 | Colchicine Tablets Wiki | 0.08 |
drug576 | Clazakizumab Wiki | 0.06 |
drug454 | COVID-19 Convalescent Plasma Wiki | 0.06 |
drug1645 | Normal saline Wiki | 0.06 |
drug1706 | Oseltamivir Wiki | 0.06 |
drug1374 | Losartan Wiki | 0.05 |
drug2116 | Ruxolitinib Wiki | 0.05 |
drug1103 | Hydroxychloroquine Sulfate Wiki | 0.04 |
drug658 | Convalescent plasma Wiki | 0.04 |
drug1613 | No intervention Wiki | 0.03 |
drug2319 | Standard of Care Wiki | 0.03 |
drug262 | Azithromycin Wiki | 0.02 |
drug1822 | Placebo Wiki | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
D001927 | Brain Diseases NIH | 0.16 |
D009748 | Nutrition Disorders NIH | 0.14 |
D020196 | Trauma, Nervous System NIH | 0.14 |
D009164 | Mycobacterium Infections NIH | 0.14 |
D003147 | Communication Disorders NIH | 0.14 |
D003693 | Delirium NIH | 0.10 |
D016769 | Embolism and Thrombosis NIH | 0.08 |
D004211 | Disseminated Intravascular Coagulation NIH | 0.07 |
D013927 | Thrombosis NIH | 0.07 |
D009765 | Obesity NIH | 0.06 |
D012769 | Shock, NIH | 0.06 |
D013313 | Stress Disorders, Post-Traumatic NIH | 0.06 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.06 |
D055371 | Acute Lung Injury NIH | 0.06 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.06 |
D000066553 | Problem Behavior NIH | 0.05 |
D054556 | Venous Thromboembolism NIH | 0.05 |
D018352 | Coronavirus Infections NIH | 0.05 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.05 |
D020246 | Venous Thrombosis NIH | 0.05 |
D011655 | Pulmonary Embolism NIH | 0.05 |
D020141 | Hemostatic Disorders NIH | 0.04 |
D004617 | Embolism NIH | 0.04 |
D001778 | Blood Coagulation Disorders NIH | 0.04 |
D013923 | Thromboembolism NIH | 0.04 |
D058186 | Acute Kidney Injury NIH | 0.03 |
D014777 | Virus Diseases NIH | 0.03 |
D040921 | Stress Disorders, Traumatic NIH | 0.03 |
D014947 | Wounds and Injuries NIH | 0.03 |
D055370 | Lung Injury NIH | 0.03 |
D001523 | Mental Disorders NIH | 0.03 |
D004194 | Disease NIH | 0.03 |
D011014 | Pneumonia NIH | 0.03 |
D001008 | Anxiety Disorders NIH | 0.02 |
D003863 | Depression, NIH | 0.02 |
D011024 | Pneumonia, Viral NIH | 0.02 |
D007239 | Infection NIH | 0.02 |
D013577 | Syndrome NIH | 0.02 |
D003141 | Communicable Diseases NIH | 0.01 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0001298 | Encephalopathy HPO | 0.16 |
HP:0005521 | Disseminated intravascular coagulation HPO | 0.07 |
HP:0001513 | Obesity HPO | 0.06 |
HP:0000708 | Behavioral abnormality HPO | 0.05 |
HP:0002625 | Deep venous thrombosis HPO | 0.05 |
HP:0002204 | Pulmonary embolism HPO | 0.05 |
HP:0001928 | Abnormality of coagulation HPO | 0.04 |
HP:0001919 | Acute kidney injury HPO | 0.03 |
HP:0001907 | Thromboembolism HPO | 0.03 |
HP:0002090 | Pneumonia HPO | 0.03 |
There are 49 clinical trials
Intensive Care Units (ICU) are stressful places where life-and-death medical decisions are made and patients' surrogate decision-makers are exposed to potentially traumatic experiences. As the number of life-prolonging procedures administered to the patient rises, the patient's quality of life falls. Thus, interventions to improve the quality of life and care of ICU patients are needed. EMPOWER is a cognitive-behavioral, acceptance-based intervention for patient surrogate decision-makers to reduce experiential avoidance of unpleasant thoughts and feelings related to thinking about patient death. By reducing surrogate's experiential avoidance, EMPOWER removes a barrier to advance care planning. EMPOWER aims to improve patient quality of life through enhancing value-directed end-of-life care while also empowering surrogates to cope with a loved one's potential impending death and adjust following the patient's ICU death or discharge. Specifically, investigators aim to: - 1: Develop EMPOWER for surrogate decision-makers of critically ill patients who are at risk of becoming incapacitated or are currently unable to communicate in the ICU. Key informants, including bereaved ICU patient caregivers and clinicians, will be asked to evaluate the EMPOWER intervention manual to increase its potential tolerability, acceptability and efficacy. - 2: Determine feasibility, tolerability, acceptability, and preliminary effects of EMPOWER on surrogate mental health. - 3: Estimate the effects of EMPOWER on patient outcomes in the months following the ICU admission. Hypothesis 1: Surrogate decision-makers who receive EMPOWER will have significantly lower levels of peritraumatic distress when compared to usual care condition at post intervention assessment (T2). Hypothesis 2: Patients whose surrogates receive EMPOWER will have more value-concordant care, better quality of life, and better quality of death. EMPOWER was first evaluated though a single site open trial (n=10). Feedback from clinicians, bereaved stakeholders and results from the open trial were then used to refine the intervention and launch a multi-center randomized controlled trial to examine clinical superiority of EMPOWER to enhanced usual care. In order to adapt to restrictions in ICU visitation and meet the needs of family caregivers impacted by the COVID-19 pandemic, a second single arm open trial is now occurring while the RCT recruitment is paused (total n of RCT & COVID-19 open trial=60).
Description: Symptoms of peritraumatic distress, as measured by the Peritraumatic Distress Inventory (adapted to fit the ICU experience), will be compared between groups at post-intervention assessment (T2). The PDI consists of 13 likert-style items and total score can range from 0 to 52. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Peritraumatic Distress Inventory Time: In the week following the intervention (T2)Description: Anticipatory grief for patients who are not deceased, as measured by the Prolonged Grief-12, will be compared between groups at one-month and three-month follow up assessments (T3 and T4).The PG-12 consists of 12 items and total score can range from 0 to 57. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Anticipatory Grief Time: One month and three months from baseline (T3 and T4)Description: Symptoms of prolonged grief disorder, as measured by the Prolonged Grief-13, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The PG-13 consists of 13 items and total score can range from 0 to 62. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Prolonged Grief Disorder Time: One month and three months from baseline (T3 and T4)Description: Symptoms of experiential avoidance, as measured by the Brief Experiential Avoidance Questionnaire, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The BEAQ consists of 15 items and total score can range from 15 to 90. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Experiential Avoidance Time: One month and three months from baseline (T3 and T4)Description: Symptoms of post-traumatic stress disorder, as measured by the Impact of Events Scale-Revised, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The IES-R consists of 22 items and total score can range from 0 to 88. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Post-Traumatic Stress Disorder Time: One month and three months from baseline (T3 and T4)Description: Logistic regression models will regress patient quality of life for EMPOWER vs. the enhanced usual care condition. Patient quality of life will be assessed using three previously validated items. Total score can range from 0 to 30. Higher total scores represent better caregiver-assessed patient quality of life. Higher scores represent better outcomes.
Measure: Patient Quality of Life Time: From baseline assessment to three-month follow upDescription: For patients who die during the study period, logistic regression models will regress patient quality of death for EMPOWER vs. the enhanced usual care condition. Quality of Death will be measured using the Caregiver Evaluation of the Quality of End-of-Life Care (CEQUEL). Total score can range from 13 to 26. Higher total scores represent better caregiver-assessed patient quality of death. Higher total scores represent better outcomes.
Measure: Patient Quality of Death Time: From baseline assessment to three-month follow upDescription: Intensity of care (measured through indication of cardiopulmonary resuscitation, dialysis, mechanical ventilation, chemotherapy, parenteral nutrition, and palliative care in the medical record) will be matched with surrogate perceptions of patient treatment preferences to create a measure of value-concordant care. Logistic regression analyses will then model the effects of EMPOWER on the odds of patients' receipt of value-concordant care. Higher odds equal better outcomes.
Measure: Value-Concordant Care Time: From baseline assessment to three-month follow upDescription: Symptoms of anxiety, as measured by the state scale of the State-Trait Anxiety Scale, will be compared between groups at one-month and three-month follow up assessments (T3 and T4).The STAI-Y state scale consists of 20 items and total score can range from 20 to 80. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Anxiety Time: One month and three months from baseline (T3 and T4)Description: Symptoms of anxiety, as measured by the Patient Health Questionnaire - 9 , will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The PHQ-9 consists of 9 items and total score can range from 0 to 27. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Depression Time: One month and three months from baseline (T3 and T4)Description: Decision regret, as measured by the Decision Regret Scale, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The decision regret scale is a one-item likert-style measure. Total score can range from 1 to 10. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Decision Regret Time: One month and three months from baseline (T3 and T4)There was an interaction between mortality, nutritional intake and the Nutrition Risk in Critically ill (NUTRIC) score suggesting that those with higher NUTRIC scores benefited the most from increasing nutritional intake. Yet limited data were in Chinese patients. The current outbreak of novel coronavirus, named COVID-19, was first reported from Wuhan, China on Dec ember 31 , 2019. There are about 16% patients need ICU admission. The objective of this study is to validation of the "NUTRIC" nutritional risk assessment tool in Chinese ICU patients diagnosed as COVID-19.
The purpose of this case series is to describe the characteristics, organ dysfunction and support and 2 week outcomes of critically ill patients with nCov infection.
Description: survival or death at 28 days
Measure: 28 day mortality Time: 28 daysDescription: days on vasopressor
Measure: vasopressor days Time: 28 daysDescription: days on mechanical ventilation during ICU stay
Measure: days on mechanical ventilation Time: 28 daysDescription: daily sequential organ function assessment score (0 minimum to 24 maximum), higher scores worse organ function
Measure: sequential organ function assessment score Time: daily for first 5 daysDescription: Percentage of patients requiring ECMO during ICU stay.
Measure: ECMO use Time: 28 daysDescription: percentage of patients requiring nitric oxide during ICU stay.
Measure: percentage nitric oxide use Time: 28 daysDescription: percentage not requiring oxygen therapy
Measure: percentage free from oxygen supplement Time: 28 daysInfection with SARS-CoV-2 or severe acute respiratory syndrome coronarvirus type 2 was highlighted in December 2019 in the city of Wuhan in China, responsible for an pandemic evolution since March 11, 2020. The infection affects all ages of life, although affecting children in a very small proportion of cases. The typical presentation of the disease combines fever (98%), cough (76%), myalgia and asthenia (18%) as well as leukopenia (25%) and lymphopenia (63%). Upper airway involvement rare. The main clinical presentation requiring hospitalization of infected patients is that of atypical pneumonia which may require critical care management (27%), and progress to an acute respiratory distress syndrome (67%) involving life-threatening conditions in almost 25% of patients diagnosed with SARS-CoV-2 infection. Other organ damage have been reported, mainly concerning kidney damage (29%) which may require renal replacement therapy in approximately 17% of patients. Neurological damage has been very rarely studied, yet reported in 36% of cases in a study including patients of varying severity. Finally, the mortality associated with this emerging virus is high in patients for whom critical care management is necessary, reported in 62% of patients. We therefore propose a prospective observational study which aim at reporting the prevalence of acute encephalopathy at initial management in Critical/Intensive care or Neurocritical care , to report its morbidity and mortality and to identify prognostic factors.
Description: ratio of patients with acute encephalopathy among the total of patients with SARS-Cov-2 infection at Critical/Intensive care or Neurocritical care admission
Measure: prevalence Time: at Critical/Intensive care or Neurocritical care admissionDescription: A favorable outcome is defined by a Glasgow Outcome Scale (GOS) of 5. The Glasgow Outcome Scale (GOS) will be determined patients charts review, phone call, and/or general practitioner interview conducted by an independent assessor. The GOS score : [1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability]
Measure: Favorable outcome Time: 3 monthsDescription: A favorable outcome is defined by a Glasgow Outcome Scale Extended (GOSe) >= 5. The Glasgow Outcome Scale Extended (GOSe) will be determined patients charts review, phone call, and/or general practitioner interview conducted by an independent assessor. The GOSe score : [1: Death, 2: Persistent vegetative state, 3: Severe disability Lower, 4: Severe disability Upper, 5: Moderate disability Lower, 6: Moderate disability Upper, 7 : Good recovery lower, 8 : Good recovery Upper]
Measure: Favorable outcome Time: 3 monthsThe primary aim is to study the short-term outcome of elderly ICU patients (≥ 70 years) suffering from COVID-19 using a multicenter and multi-national approach The secondary aim is to investigate the properties of a simple frailty index in this cohort, and in particular if this is an instrument that can be used in resource and outcome prediction in this group To create hypothesis for further studies, in particular on various outcome prediction To create hypothesis for further studies, in particular on various outcome prediction
Description: Fragilty will be measured by using the Clinical frailty scale (CFS) a global clinical measure of fitness and frailty in elderly people (1=very fit to 9= terminally ill)
Measure: Fragilty Time: pre-admissionThe symptoms of respiratory distress caused by COVID-19 may be reduced by drugs combining anti-inflammatory and antiviral effects. This dual effect may simultaneously protect severely-ill patients and reduce the viral load, therefore limiting virus dissemination We want to demonstrate the superiority of naproxen (anti-inflamatory drug) treatment addition to standard of care compared to standard of care in term of 30-day mortality.
Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France. We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.
Description: Mortality at day 28
Measure: Mortality at day 28 Time: day 28Description: severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No
Measure: severe complications Time: up to day 28Description: Delay in imaging in hours
Measure: Imaging Time: day 1Description: delay in microbiological diagnosis in hours
Measure: Delay in Microbiological diagnosis Time: day 1Description: Antiviral therapy Yes / no
Measure: Antiviral therapy Time: up to day 28Description: Antibiotic therapy Yes / No
Measure: Antibiotic therapy Time: day 28Description: Covid-19 treatments Yes / No
Measure: Covid-19 treatments Time: up to day 28Description: number
Measure: Patients receiving renal replacement therapy Time: up to day 28Description: number
Measure: Patients receiving mechanical ventilation Time: up to day 28Description: Patient alive at day 28 : yes / No
Measure: Vital status Time: day 28The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.
Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 3Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 14Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 21Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 28Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day of transfer from ICU, if earlier than 28 days.Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 3Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 7Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 14Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 21Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 28Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day of transfer from ICU, if earlier than 28 days.Description: All-cause mortality
Measure: All-cause mortality Time: Till day 28Description: Any AE / SAE or event of clinical significance observed during the study.
Measure: Incidence of AE / SAE or event of clinical significance Time: Till day 28Description: Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.
Measure: SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample Time: At days 3, 7, 14, 21, and 28Description: ICU length of stay
Measure: ICU length of stay Time: Till day 28Description: Duration of mechanical ventilation
Measure: Duration of mechanical ventilation Time: Till day 28Description: Duration of hospitalization
Measure: Duration of hospitalization Time: Till day 28Description: Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.
Measure: Clinical improvement Time: From base line at day 14 & Day 28Description: Time (in days) from treatment initiation to death.
Measure: Time (in days) from treatment initiation to death Time: Till day 28The aim of our study is to observe the intensive care course in 30-50 COVID-19 patients with regard to cardiovascular risk factors and biomarkers. The primary objective of this study is to investigate the cardiovascular risk and its impact on cardiovascular complications in COVID-19 patients in intensive care units. This study is designed to investigate correlations and to investigate factors influencing the course of the new viral disease COVID-19 in intensive care. Previous scientific findings are still rare due to the relevance of the disease, therefore this study is also explorative and not exclusively based on a hypothesis. The cardiovascular risk will be assessed upon admission to the intensive care unit and subsequently the course of biomarkers (see below) will be analysed in a cohort study (no, low and high cardiovascular risk).
Description: Troponin courses in the intensive care unit are analyzed in consideration of the respective cardiovascular risk.
Measure: ICU CV risk and Biomarker (e.g. Troponin) Time: through study completion, up to 4 weeksDescription: The 30-day mortality during the ICU stay is determined and divided into appropriate cardiovascular risk groups.
Measure: CV risk and Outcome during ICU stay Time: through study completion, up to 4 weeksSince the outbreak of a syndrome of acute respiratory distress associated to a novel coronavirus 2 (SARS-Cov2) that began in China, Europe and France have to face a sanitary emergency with critically care support when the patient evolves to an acute respiratory distress (ARDS). In the context of supply shortages (ventilators, bed capacities) that countries have to deal with, data were lacking of characteristics and outcomes of patients admitted to intensive care unit (ICU). the purpose of this project is to report the epidemiology and the outcomes of a French cohort of critically ill patients with SARS-Cov2
Description: Variation of age between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Measure: Variation of age between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU Time: from day 1 of admissionDescription: Variation of medical history between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Measure: Variation of medical history between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU Time: from day 1 of admissionDescription: Variation of chronic drug used between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Measure: Variation of chronic drug used between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU Time: from day 1 of admissionDescription: Variation of chest CT scan at admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Measure: Variation of chest CT scan at admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU Time: from day 1 of admissionDescription: Variation of respiratory support at ICU admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Measure: Variation of respiratory support at ICU admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU Time: from day 1 of admissionInflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.
Description: nM;
Measure: ETP (AUC) without rhThrombomodulin (rhTM) Time: 6 monthsDescription: nM;
Measure: ETP (AUC) with rhThrombomodulin (rhTM) Time: 6 monthsDescription: Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM
Measure: ETP-ratio Time: 6 monthsDescription: Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors
Measure: ETP-Normalisation Time: 6 monthsThe Risk stratification in COVID-19 patients in the ICU (RISC-19-ICU) registry was founded during the emerging SARS-CoV-2 pandemic. COVID-19 is a novel disease caused by infection with the SARS-CoV-2 virus that was first described in December 2019. The disease has spread exponentially in many countries and has reached global pandemic status within three months. According to first experience, hospitalization was required in approximately 20 % of cases and severe, life-threatening illness resulted in approximately 10 %. In some countries, health care systems were overwhelmed by the rapid increase in critically ill patients that far exceeded their capacity. It is thus of utmost importance to gain knowledge about the characteristics and course of critically ill patients with COVID-19 and to stratify these patients according to their risk for further deterioration. A key part of fighting this pandemic is to exchange scientific information and advance our understanding of the disease. The Risk stratification in COVID-19 patients in the ICU (RISC-19-ICU) registry aims to collect an anonymized dataset to characterize patients that develop life-threatening critical illness due to COVID-19 and make it accessible to collaborative analysis. The data collected may be composed of a core dataset and/or an extended dataset. The core dataset consists of a basic set of parameters, of which many are commonly generated during treatment of critically ill patients with COVID-19 in an intensive care unit (the individual parameters are marked yellow in the attached case report forms, and are clearly marked on the electronic case report forms during data entry). The extended dataset consists of parameters that may be measured during treatment of critically ill patients with COVID-19 in an intensive care unit, depending on clinical practice, indication and availability of the measurement method. The data accumulating in the registry as the pandemic or subsequent waves develop are made available to the collaborators to support an optimal response to the pandemic threat. The information gained on the initial characteristics and disease course via the RISC-19-ICU registry may contribute to a better understanding of the risk factors for developing critical illness due to COVID-19 and for an unfavorable disease course, and thus support informed patient triage and management decisions. Initial research questions are (I) to perform risk stratification of critically ill patients with COVID-19 to find predictors associated with the development of critical illness due to COVID-19: characterization of the study population, which are critically ill patients with COVID-19: inflammation, oxygenation, circulatory function, among other parameters collected in the registry, and (II) to perform risk stratification of critically ill patients with COVID-19 to predict outcome after ICU admission (ICU mortality, ICU length of stay): characterization of patients grouped by disease course in the ICU, based on inflammation, oxygenation, circulatory function, and other parameters collected in the registry.
The outbreak at covid-19 is caused by the SARS-CoV-2 virus. This virus can be responsible for severe respiratory failure but also for extra-respiratory organ dysfunctions associated with severe inflammatory stress. The endothelium is an important structure of the blood vessels and is implicated in the organ failure of many patients admitted in intensive care units. It could be affected by the virus and its alteration may explain the organ dysfunction of covid-19 ICU patients as well as the thrombotic processes frequently obstructed in this infection.
Description: Plasma of covid-19 patients will be tested for endothelial injuries, notably with the measurement of InterCellular Adhesion Molecule 1 level by Enzym-Linked Immunosorbent Assay. The association of these levels with 28-days mortality will be evaluated as prognosis markers.
Measure: Association of InterCellular Adhesion Molecule-1 plasma level with 28 days mortality Time: 24 hoursDescription: Endothelin-1 will be assessed in blood as a maker of endothelial injuries, expressed in pg/mL. its association with 28 -days mortality will be evaluated.
Measure: Association of Endothelin-1 plasma level with 28 days mortality Time: 24 hoursDescription: Vascular Endothelial Growth Factor A plasma level will be measured in blood as a marker of endothelial injury expressed in pg/mL. its association with 28 -days mortality will be evaluated.
Measure: Association of Vascular Endothelial Growth Factor A plasma level with 28 days mortality Time: 24 hoursDescription: This soluble receptor is another marker of endothelial injury and will be measured in blood and expressed as pg/mL. Its association with 28-days mortality will be evaluated.
Measure: Association of soluble Vascular Endothelial Growth Factor Receptor type 1 with 28 days mortality Time: 24 hoursDescription: syndecan -1 is a marker of degradation of glycocalyx, raised during endothelial injury. It will be measured in blood and expressed as pg/mL. Its assocation with 28-days mortality will be evaluated.
Measure: Association of syndecan -1 plasma level with 28 days mortality Time: 24 hoursDescription: D-dimers si marker of enhanced thrombotic activity. It may be increased during covid-19 disease but its correlation with endothelial injury is not known. It will be measured in blood and expressed as microgrammes/L, and then correlated with ICAM-1 plasma levels
Measure: Association of D-dimers plasma levels with thrombotic events Time: 24 hoursDescription: This marker may be raised during endothelial injury and may explained thrombotic status of covid-19 patients. Its blood levels will be measured and expressed as international unit/dL, and correlated with ICAM-1 plasma levels
Measure: Association of von Willebrandt Factor with thrombotic events Time: 24 hoursDescription: Clot Stiffness and its fibrinogen and platelet contributions (expressed in kPa) will be measured as novative approach, using Quantra (Stago Inc) device, to explore hemostasis alterations of covid-19 patients.
Measure: Association of Viscoelastic testing with thrombotic events Time: 24 hoursFor limiting COVID-19 spreading, the World Health Organisation (WHO) recommended worldwide confinement on 2010. In France, unessential institutions were closed on March 14th and population confinement was decided on March 17th. Quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger COVID-19 outbreak highlighted a considerable proportion of health care workers (HCW) with depression, insomnia, anxiety and distress symptoms. In front line, facing the virus with the fear of contracting it and contaminate their closest. During previous outbreaks (H1N1, SARS), HCWs have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7). In France, Covid 19 outbeak led to increase ICU bed capacity with a full reorganization of the human resources. Some caregivers were reassigned to newly setup units admitting or not Covid-19 patients. In the same time, non-caregivers were also encouraged to work at home whenever possible. Thus, every hospital staff member's private and professional life could be altered by the Covid-19 outbreak. As all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our Tertiary University Hospital, (6300 employees). Secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed
Description: Mesured by STAY Scale
Measure: Anxiety Time: 15 to 45 days after the beginning of the outbreakDescription: Participant suffering of Insomnia
Measure: Insomnia Time: 15 to 45 days after the beginning of the outbreakDescription: Participant suffering of catastrophism
Measure: Catastrophism Time: 15 to 45 days after the beginning of the outbreakThis is a randomized, double blind, two arms, placebo controlled, clinical trial to study to evaluate the the safety and efficacy of Mycobacterium w in combination with standard of care versus placebo with standard of care for preventing the progression of COVID-19 disease and for reduction in transfer to ICU in COVID-19 infected patients admitted to the hospital.
Description: To compare the difference in proportion of patients with increased disease severity
Measure: Number of patients with increased disease severity Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.Description: To evaluate safety of Mw in COVID-19 patients admitted to hospital
Measure: Incidence of adverse events and serious adverse events (Safety) Time: Till day 28Description: To compare the proportion of patients discharged from hospital
Measure: Number of COVID-19 patients discharged from hospital Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.Description: To compare the proportion of patients transfer to ICU
Measure: Number of COVID-19 patients transfer to ICU Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.Description: To compare the proportion of patients with reduction in disease severity by 1 ordinal scale
Measure: Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.Description: To compare the proportion of symptom free patients
Measure: Number of of symptom free patients Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.Delirium and acute neurocognitive impairment are increasingly observed in adult and pediatric patients with COVID-19. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed for COVID-19. The value of biomarkers of neuroaxonal injury was proven in preliminary studies. These biomarkers could thus contribute to the systematic detection of neurocognitive impairment in patients with COVID-19. Due to worldwide increasing numbers of hospitalized patients with COVID-19, biomarkers of neuroaxonal injury are highly valuable to detect and monitor cognitive impairment, especially with regard to limited resources available to perform time-consuming brain imaging. Biomarkers of neuroaxonal injury are therefore not only of great interest to detect neurocognitive impairment but also to quantify the severity of brain injury in patients with COVID-19.
Description: Assessment of neurocognitive impairment using validated tools
Measure: Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19 compared to patients without COVID-19 Time: Day 90Description: Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood samples
Measure: Change in neuroaxonal injury biomarker levels in patients with COVID-19 compared to patients without COVID-19 Time: Change from baseline biomarker levels at day 28Description: Assessment of the neurocognitive performance of patients using validated tests (e.g. Short Blessed Test)
Measure: Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 Time: Day 90Description: Assessment of the change in the neurocognitive performance of patients using validated tests (e.g. IQCODE)
Measure: Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 Time: Change from baseline IQCODE results at day 90Description: Assessment of the overall quality of life using validated tests [e.g. Modified Rankin Scale with a range from 0 (no symptoms) to 6 (dead)]
Measure: Quality of life in patients with COVID-19 compared to patients without COVID-19 after hospital discharge Time: Day 90Description: Cumulative days in hospital
Measure: Length of hospital stay in patients with COVID-19 compared to patients without COVID-19 Time: 1 yearDescription: Survival after 90 days
Measure: 90-day survival in patients with COVID-19 compared to patients without COVID-19 Time: Day 90The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.
Description: SF-36 score
Measure: Quality of Life score Time: up to 12 months after dischargeDescription: Montreal Cognitive Assessment (MoCA) score
Measure: cognitive dysfunction Time: up to 12 months after dischargeDescription: (FSS-ICU)
Measure: Functional Status Score Time: up to 12 months after dischargeDescription: MRC neuromuscular Assessment
Measure: Physical Disability Time: up to 12 months after dischargeDescription: Impact Event Score
Measure: Psychological Sequelae Time: up to 12 months after dischargeDescription: hospital anxiety and depression scale
Measure: hospital anxiety and depression Time: up to 12 months after dischargeDescription: including ventilator associated pneumonia, GI hemorrhage, Deep Vein Thrombosis (DVT) /Pulmonary Embolus (PE), sacral decubitus ulcer, delirium, ICU acquired weakness
Measure: ICU related complications Time: hospitalization up to 6 weeksDescription: measure the location (home, rehabilitation center, nursing home
Measure: hospital discharge location Time: hospital discharge up to 6 weeksDescription: number of days admitted to the ICU
Measure: lCU length of stay Time: hospitalization up to 6 weeksDescription: number of days admitted to the hospital
Measure: hospital length of stay Time: hospitalization up to 6 weeksThe novel coronavirus (COVID-19) is affecting the way many people live their lives, including seeking medical care and maintaining good self-care to keep healthy. Additionally, in the event many people become critically ill at once, COVID-19 has the possibility of overwhelming hospitals to the point where they have to make decisions about how to determine who receives intensive care and life-support measures. Many hospitals as well as local or state governments have been working on policies to determine how to make these decisions. This study seeks to learn about how COVID-19 has affected the way patients and healthcare providers care for themselves and about their thoughts and concerns about policies that may "ration" life-support resources.
Description: Improvement in knowledge item score of 2 points on follow up after intervention delivery and at final follow up
Measure: Improvement in knowledge surrounding SRA policy Time: 1 month, 6 monthsDescription: Improvement in anxiety scale of 2 points responses on follow up after intervention delivery and at final follow up
Measure: Improvement in anxiety surrounding SRA policy Time: 1 month, 6 monthsDescription: Improvement in trust scale of 2 points responses on follow up after intervention delivery and at final follow up
Measure: Improvement in trust surrounding SRA policy Time: 1 month, 6 monthsSevere COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.
Description: Patients with symptomatic pulmonary embolism confirmed on the CT-angiography and those with a swollen limb and confirmed deep venous thrombosis on compression ultrasound were considered to have "symptomatic venous thromboembolisms". The remaining patients with positive limb ultrasound or CT-angiography were considered to have "asymptomatic venous thrombembolism"
Measure: Venous thromboembolisms Time: 7 daysDescription: Deaths from all causes during the follow-up
Measure: Deaths Time: 7 daysThis is a case series of patients with COVID-19 admitted to the largest university hospital in Sao Paulo, Brazil, during the 2020 COVID-19 pandemic. Data will be collected prospectively and retrospectively. The main objective is to describe the characteristics of critically ill patients with COVID-19 and their clinical outcomes, and to identify risk factors associated with survival, to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.
Description: the proportion of patients who survive to ICU discharge or for 28 days in the ICU
Measure: ICU survival at 28 days Time: 28 daysDescription: the proportion of patients who survive to hospital discharge or for 60 days in the hospital
Measure: Hospital survival at 60 days Time: 60 daysDescription: Number of days under invasive ventilatory support
Measure: Duration of mechanical ventilation Time: 28 daysDescription: Proportion of patients who received renal replacement therapy during the ICU stay
Measure: Need for renal replacement therapy Time: 28 daysDescription: percentage of patients who developed complications during the ICU stay: thromboembolic events, ventilator associated pneumonia, secondary infections, cardiovascular complications
Measure: Complications during the ICU stay Time: 28 daysThis multicenter before-after study aimed to determine the impact of infection related to SARS-CoV-2 on the incidence of ICU-acquired multidrug resistant (MDR) bacteria.
Description: percentage of patients with ICU acquired MDR bacteria colonization
Measure: Cumulative incidence of ICU-acquired colonization related multidrug resistant bacteria Time: from D3 until day 28 after ICU admissionDescription: percentage of patients with ICU acquired MDR bacteria infection
Measure: Cumulative incidence of ICU-acquired infection related to multidrug resistant bacteria Time: from D3 until day 28 after ICU admissionDescription: the number of days Under mechanical ventilation
Measure: Mechanical ventilation duration Time: from D1 until day 28 after ICU admissionDescription: death in the ICU
Measure: mortality Time: from D1 until day 28 after ICU admissionDescription: the number of days of hospitalization in the ICU
Measure: length of stay in intensive care unit Time: from D1 until day 28 after ICU admissionThe recent pandemic of the COVID-19 disease has caused a national health emergency due to its severity and the clinical and social consequences of the disease. Crude mortality in Spain is 9.2%. However, the causes of death of critically ill patients with COVID-19 are unknown. To date, no treatment has been shown to be effective for the 2019-SARS-CoV-2 infection is recommended. Supportive care and isolation are recommended for infected individuals. Currently, observational studies on critically ill patients with COVID-19 have small samples. The objective is to evaluate the incidence of mortality and morbidity in COVID-19 disease in this group of critically ill patients, as well as the risk factors associated with mortality and the effectiveness of the treatments used compassionately.
Description: rate (%)
Measure: ICU mortality Time: events during the ICU stay, up to 3 monthsDescription: rate (%)
Measure: hospital mortality Time: events through study completion during the hospital stay, up to 5 monthsDescription: rate (%)
Measure: 28-day mortality Time: events through study completion considered from ICU admission up to 28 daysDescription: rate (%). Incidence of outcome measures (ICU mortality), and appearance of complications (pneumonia or bacteriemia during ICU stay).
Measure: effectiveness of treatment Time: through study completion considered from ICU admission until ICU discharge, up to 3 monthsDescription: days
Measure: length of ICU stay Time: through study completion during ICU stay considered from ICU admission until ICU discharge as date of inclusion until the date of first documented discharge or date of death from any cause, whichever came first, assessed up to 3 monthsDescription: days
Measure: length of hospital stay Time: through study completion during ICU stay considered from ICU admission until ICU discharge as date of inclusion until the date of first documented hospital discharge or date of death from any cause, whichever came first, assessed up to 5 monthsDescription: rate (%)
Measure: ventilator-associated pneumonia Time: through duration of invasive ventilatory support period (from intubation date until date of successful extubation) through study completion up to 3 monthsDescription: rate (%)
Measure: bacteriemia Time: through study completion, up to 28-daysDescription: rate (%)
Measure: barotrauma Time: through study completion, up to 28-daysDescription: days
Measure: duration of mechanical ventilation Time: period of invasive controlled ventilatory support from date of orotraqueal intubation until date of successful extubation or assessed up to 3 months whichever came firstCOVID-19 DISEASE Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, severe acute respiratory syndrome from COVID-19, that was first recognized in Wuhan, China, in December 2019. While most people with COVID-19 develop mild or uncomplicated illness, approximately 14% develop severe disease requiring hospitalization and oxygen support and 5% require admission to an intensive care unit. In severe cases, COVID-19 can be complicated by acute respiratory disease syndrome (ARDS) requiring prolonged mechanical ventilation, sepsis and septic shock, multiorgan failure, including acute kidney, liver and cardiac injury. ARDS REHABILITATION Critically ill people who undergo prolonged mechanical ventilation often develop weakness, with severe symmetrical weakness of and deconditioning of the proximal musculature and of the respiratory muscles (critical illness neuropathy/myopathy).These individuals also develop significant functional impairment and reduced health-related quality of life (HRQL) up to 2 and 5 years after discharge. ARDS survivors may complain of depression, anxiety, memory disturbances, and difficulty with concentration often unchanged at 2 and 5 years. Less than half of all ARDS survivors return to work within the first year following discharge, two-thirds at two years, and more than 70% at five years. Early physiotherapy (PT) of people with ARDS has recently been suggested as a complementary therapeutic tool to improve early and late outcomes. The aims of PT programs should be to reduce complications of immobilization and ventilator-dependency, to improve residual function, to prevent new hospitalisations, and to improve health status and HRQL. Physiotherapy in critical patients is claimed also to prevent and contribute to treat respiratory complications such as secretion retention, atelectasis, and pneumonia. Early mobilization and maintenance of muscle strength may reduce the risk of difficult weaning, limited mobility, and ventilator dependency. Lastly, pulmonary rehabilitation in ICU in mechanically ventilated subjects may reduce length of stay in ICU up to 4.5 day, shorten mechanical ventilation of 2.3 days and weaning by 1.7 days. The aim of this study is to investigate how early pulmonary and motor rehabilitation impacts on length of hospital admission (ICU and acute ward) and early and late outcomes inpatients that develop ARDS due to COVID-19.
Description: days of ICU stay
Measure: Length of ICU stay Time: up to 60 daysDescription: days of hospital stay
Measure: Length of hospital stay Time: up to 90 daysThe study will prospectively collect data from patients with Covid-19 admitted to the Västerås Intensive Care Unit, Västerås Hospital. Demographic, clinical, radiographic and laboratory characteristics will be recorded. Analysis of data to identify predictors of disease severity, mortality and treatment response.
Objective of this observational multicentric retrospective-prospective study is to describe the number and the characteristics of patients with Reverse Transcription Polymerase Chain Reaction (RT-PCR) for SARS-CoV2 positivity admitted to Intensive Care Units during the first 6 months of epidemic.
Description: Number and characteristics of patients with COVID-19 admitted in Intensive Care Units every week.
Measure: Overall number and characteristics of patients with COVID-19 in ICU Time: 22nd February - 22nd August 2020The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, the observed associations between different comorbidities and chronic medications have not fully been related to the frequencies of the same comorbidities and chronic medications in age- and sex-matched controls from the general population. This is important since some of the proposed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of the disease. By combining several registries, we will compare, on several comorbidities such as hypertension and diabetes and several medications such as immunosuppressant drugs and Angiotensin Converting Enzyme (ACE)-inhibitors, the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a set 8000 age- and sex-matched controls.
Description: Odds ratio of intensive care treated patients with COVID-19 having ongoing treatment with drugs blocking the Renin-Angiotensin-Aldosterone-System (RAAS), statins, immunosuppressant drugs, oral anticoagulant drugs, oral thrombocyte aggregation inhibitors or antiviral drugs.
Measure: Chronic medications as risk factor of intensive care for COVID-19 Time: Drug dispensation within 6 months prior inclusionDescription: Odds ratio of intensive care treated patients with COVID-19 having been diagnosed with diabetes typ I, diabetes type II, ischemic heart disease, other heart disease, cerebrovascular disease, cancer, chronic renal failure, chronic obstructive pulmonary disease (COPD) asthma, obesity, immunosuppressed disease or systemic inflammatory disease.
Measure: Comorbidities as risk factor of intensive care for COVID-19 Time: 5 years prior to inclusionDescription: Odds ratio of patients who have died during intensive care with COVID-19 having ongoing treatment with drugs blocking the Renin-Angiotensin-Aldosterone-System (RAAS), statins, immunosuppressant drugs, oral anticoagulant drugs, oral thrombocyte aggregation inhibitors or antiviral drugs.
Measure: Chronic medications as risk factor of death during intensive care for COVID-19 Time: Drug dispensation within 6 months prior inclusionDescription: Odds ratio of patients who have died during intensive care with COVID-19 having been diagnosed with diabetes typ I, diabetes type II, ischemic heart disease, other heart disease, cerebrovascular disease, cancer, chronic renal failure, chronic obstructive pulmonary disease (COPD) asthma, obesity, immunosuppressed disease or systemic inflammatory disease.
Measure: Comorbidities as risk factor of death during intensive care for COVID-19 Time: 5 years prior to inclusionThis is an observational study exploring the levels of mobility and rehabilitation in patients admitted to critical care with a confirmed diagnosis of COVID-19
Description: Highest level of mobility achieved at the point of ICU discharge
Measure: Mobility level Time: At ICU discharge, an average of 3 weeksDescription: Time taken to first mobilise, defined as sitting on the edge of the bed or higher
Measure: Time taken to first mobilise Time: during ICU admission, up to 3 weeksDescription: Discharged to home, home with rehab, or a community rehab facility
Measure: Discharge location Time: Hospital discharge, up to 2 monthsPatients who are critically ill with COVID-19 requiring life support in an intensive care unit (ICU) have increased risk of morbidity and mortality. Currently the ICU community does not know what effect the disease, the ICU admission, physiotherapy interventions and life support have on their long-term quality of life and whether they can return to their pre-illness level of function following ICU. COVID-Recovery will describe the physiotherapy interventions delivered to critically ill patients with COVID-19. In survivors, COVID-Recovery will utilise telephone follow-up of ICU survivors to assess disability-free survival and quality of life at 3 and 6 months after ICU admission. Additionally, COVID-Recovery will identify if there are predictors of disability-free survival. COVID-Recovery will aim to select up to 300 patients diagnosed with COVID-19 from ICUs in Australia. If they survive to hospital discharge, patients will be invited to receive a telephone questionnaire at 3 and 6 months after the ICU admission that aims to assess their long-term outcomes, including physical, cognitive and emotional function, quality of life, and whether they have been able to return to work following ICU discharge. COVID-Recovery will also aim to investigate the human aspect of COVID-19 by further investigating a sub-set of patients. COVID-Recovery will recruit between 15-30 of these patients and a family member, so COVID-Recovery can explore the patient experience of being admitted to the ICU and treated for COVID-19, as well as illuminate and explore the experience of having a close relative admitted and treated for COVID-19.
Description: The physiotherapy interventions provided to patients with COVID-19 admitted to the ICU and health outcomes
Measure: Physiotherapy intervention Time: During the ICU stay until 3 monthsDescription: a composite measure of WHODAS 2.0 - 12 level and hospital survival
Measure: Disability-free survival Time: 6 monthsDescription: Physiotherapist reported barriers to delivering the intervention
Measure: The reported barriers to delivering physiotherapy interventions Time: During the ICU stay until 3 monthsDescription: Adverse events that require the intervention to be ceased for medical intervention
Measure: Adverse events during physiotherapy interventions Time: During the ICU stay until 3 monthsDescription: Health related quality of life measured with EQ5D-5L score from 0 to 100
Measure: Health status Time: 6 monthsDescription: World Health Organization Disability Assessment Schedule 2.0 12L
Measure: Global function Time: 6 monthsDescription: Montreal Cognitive Assessment Blind
Measure: Cognitive function Time: 6 monthsDescription: Hospital Anxiety and Depression Scale
Measure: Anxiety and depression Time: 6 monthsDescription: Impact of Events Scale Revised
Measure: Screening for post-traumatic distress Time: 6 monthsDescription: WHODAS 2.0
Measure: Work Status Time: 6 monthsDescription: Qualitative interviews
Measure: Phenomenological data of the patient and family experience Time: 6 monthsThe purpose of this study is to determine if therapeutic dose anticoagulation (experimental group) improves 30-day mortality in participants with COVID-19 compared to those patients receiving the intermediate dose prophylaxis (control group). Following screening, subjects will be randomized 1:1 to intermediate dose prophylaxis or therapeutic dose anticoagulation treatment arms.Treatment will continue for 28 days, followed by a 6 month follow-up period.
Description: Comparison of number of COVID-19 positive patients who have died within 30 days of starting treatment on each treatment arm
Measure: 30-day mortality Time: 30 daysDescription: Comparison of length of ICU stay in days between each treatment arm.
Measure: Length of Intensive Care Unit (ICU) Stay in Days Time: 6 monthsDescription: Comparison of number of documented VTE, arterial thrombosis and microthrombosis events on each treatment arm
Measure: Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events Time: 6 monthsDescription: Comparison of major and clinically-relevant non-major bleeding events on each treatment arm, as defined by the International Society of Thrombosis and Haemostasis (ISTH) criteria.
Measure: Number of major and clinically relevant non-major bleeding events Time: 6 monthsIntroduction: Survivors of acute respiratory failure develop persistent muscle weakness and deficits in cardiopulmonary endurance combining to limit physical functioning. Early data from the Covid-19 pandemic suggest a high incidence of critically ill patients admitted to intensive care units (ICU) will require mechanical ventilation for acute respiratory failure. Covid-19 patients surviving an admission to the ICU are expected to suffer from physical and cognitive impairments that will limit quality of life and return to pre-hospital level of functioning. In this present study, the investigators will evaluate the safety and feasibility of providing a novel clinical pathway combining ICU after-care at an ICU Recovery clinic with physical therapy interventions. Methods and Analysis: In this single-center, prospective (pre, post cohort) trial in patients surviving ICU admission for Covid-19. The investigators hypothesize that this novel combination is a) safe and feasible to provide for patients surviving Covid-19; b) improve physical function and exercise capacity measured by performance on 6-minute walk test and Short Performance Physical battery; and c) reduce incidence of anxiety, depression and post-traumatic stress assessed with Hospital Anxiety and Depression Scale and the Impact of Events Scale-revised. Safety will be assessed by pooled adverse events and reason for early termination of interventions. Feasibility will be assessed by rate of adherence and attrition. Repeated measures ANOVA will be utilized to assess change in outcomes from at first ICU Recovery Clinic follow-up (2-weeks) and 3- and 6-months post hospital discharge. Ethics and Dissemination: The trial has received ethics approval at the University of Kentucky and enrollment has begun. The results of this trial will support the feasibility of providing ICU follow-up and physical therapy interventions for patients surviving critical illness for Covid-19 and may begin to support effectiveness of such interventions. Investigators plan to disseminate trial results in peer-reviewed journals, as well as presentation at physical therapy and critical care national and international conferences.
Description: Incidence of adverse events, quantified by pain or discomfort that causes termination of interventions; a fall (with or without injury) during interventions or directly related to interventions such as fall due to fatigue; and physiologic event/abnormality that warrants termination of interventions or medical follow-up including bradycardia, tachycardia, and emergent hypertension
Measure: Adverse events (safety) Time: through study completion, an average of 3-monthsDescription: Feasibility will be assessed by the consent rate (number of patients agreed to participate/number of patients approached for consent) and adherence attendance measured by the percentage of sessions patient participated divided total number of scheduled appointments. Adherence will also be prospectively assessed by total duration of exercise, dosage and intensity of exercises as described above. Attrition will be quantified by number of patients lost to follow-up.
Measure: Feasibility (success of consent process, adherence, and attrition) Time: through study completion, an average of 3-monthsDescription: Distance walked on six-minute walk test performed in line with the ATS/ERS Guidelines as measure of exercise capacity
Measure: Six minute walk test Time: Assessed at baseline, and repeated 3- and 6-months post hospital dischargeDescription: Short Performance Physical Battery (SPPB) is a performance-based physical function test with components of balance, repetitive five times sit-to-stand for time, and 4-meter habitual gait speed. Higher scores on SPPB indicate better physical function.
Measure: Short Performance Physical Battery Time: Assessed at baseline, and repeated 3- and 6-months post hospital dischargeDescription: Health-related quality of life (HRQoL) will be measured by self-report questionnaire, the Five Dimension Euro-Quality of Life (EQ-5D) that includes a visual analog scale with rating for overall HRQoL (0-100)
Measure: Quality of life (EQ-5DL) Time: Assessed at baseline, and repeated 3- and 6-months post hospital dischargeDescription: Cognitive function will be assessed by the Montreal Cognitive Assessment (MOCA) with <23/30 distinguishing mild cognitive impairment. If the patient participating in telemedicine through Zoom then the MOCA-Blind version will be completed.
Measure: Cognitive function Time: Assessed at baseline, and repeated 3- and 6-months post hospital dischargeDescription: Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS), a fourteen-item scale with subset scores of >8/21 indicating anxiety or depression
Measure: Anxiety and Depression Time: Assessed at baseline, and repeated 3- and 6-months post hospital dischargeDescription: Distress and Post-traumatic stress disorder (PTSD) will be assessed through the Impact of Events Scale-Revised (IES-R), a 22-item self-report measure, with scores >35/88 recommending provisional diagnosis of PTSD
Measure: PTSD and distress Time: Assessed at baseline, and repeated 3- and 6-months post hospital dischargeDescription: For patients previously employed, the return to work will be assessed using the self-report survey instrument designed for ICU follow-up
Measure: Return to work Time: Assessed at baseline, and repeated 3- and 6-months post hospital dischargeDescription: Readmission rate and morality with be assessed
Measure: Secondary complication Time: Assessed 3 and 6-months post hospital dischargeCritically ill patients with COVID-19 have hospitalized in an ICU due to the closer monitoring and therapy. In fact, ICU admissions are dependent on the severity of illness and the ICU capacity of the health-care system. Hence, it may be need a new scoring system for contagious critically ill patients.
Description: To compare confirmed COVID-19 cases with suspected COVID-19 cases in critical care units.
Measure: Polymerase Chain Reaction (PCR) test Time: 5 daysDescription: To use symptoms, medical history, computed tomography and laboratory examinations for scoring system to detect suspected COVID-19 cases admitted to the intensive care units.
Measure: A scoring system for patients to be admitted to the intensive care unit Time: 5 daysAround1 in 4 COVID-19 patients suffer lung failure needing life-saving support from a breathing machine. Any patient needing this support requires drugs to keep them sleepy, or "sedated" to be comfortable on this machine. Sedation is made possible by using drugs given through a vein. Unfortunately, these drugs are in short supply worldwide due to the high number of COVID-19 patients needing these machines. Another way to provide sleep is by using gases that are breathed in. These are used every day in operating rooms to perform surgery. These gases, also called "inhaled agents" can also be used in intensive care units and may have several important benefits for patients and the hospital. Research shows they may reduce swelling in the lung and increase oxygen levels, which allows patients to recover faster and reduce the time spent on a breathing machine. In turn, this allows the breathing machine to be used again for the next sick patient. These drugs may also increase the number of patients who live through their illness. Inhaled agents are widely available and their use could dramatically lesson the pressure on limited drug supplies. This research is a study being carried out in a number of hospitals that will compare how well patients recover from this illness depending on which type of sedation drug they receive. The plan is to evaluate the number who survive, their time spent on a breathing machine and time in the hospital. This study may show immediate benefits and may provide a cost effective and practical solution to the current challenges caring for patients and the hospital space, equipment and drugs to the greatest benefit. Finally, this trial will be a team of experts in sedation drugs who care for COVID-19 patients who need lifesaving treatments.
Description: Does the use of inhaled volatile anesthetic-based sedation regimen improve participant hospital mortality as compared to standard intravenous sedation regimen with a 10% difference between groups for 752 participants.
Measure: Hospital Mortality Time: 2 yearsDescription: Does the use of inhaled volatile anesthetic-based sedation regimen improve participant ventilation outcomes after 30 days post enrollment, as compared to standard intravenous sedation regimen for 200 participants
Measure: Ventilator-Free Days Time: 30 daysDescription: Does the use of inhaled volatile anesthetic-based sedation regimen improve participant time spent in ICU, 30 days post enrollment, as compared to standard intravenous sedation regimen for 128 participants
Measure: ICU-Free Days Time: 30 daysDescription: Does the use of inhaled volatile anesthetic-based sedation regimen improve participant quality of life outcomes at 3 and 12 months post discharge as compared to standard intravenous sedation regimen for 144 participants. The EQ-5D questionnaire will be completed at both time points
Measure: Participant Quality of Life at 3 and 12 months after discharge Time: 365 daysDescription: To evaluate participant median daily oxygenation (PaO2/FiO2) at 3 days post enrollment
Measure: Median Daily Oxygenation Time: 3 daysDescription: To evaluate participant need for adjunctive ARDS therapies (prone, nitric oxide, paralysis, ECMO) during ICU stay
Measure: Adjunctive ARDS therapies Time: 30 daysDescription: To evaluate the number of hospital-free days for participants, 60 days after enrollment
Measure: Hospital-Free Days Time: 60 daysDescription: To evaluate participant disability at 3 and 12 months post discharge. The World Health Organization Disabiltity Assessment Score (WHODAS 2.0) will be completed at both timepoints. The scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed. This method is referred to as simple scoring because the scores from each of the items are simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items.
Measure: Disability Time: 365 daysDescription: Quality of Life (QALY) assessment to be calculated using the EQ-5D, comparison costs at 3 and 12 months post discharge, costs associated with hospital stay, devices and sedative costs
Measure: Cost Utility Analysis Time: 365 daysDescription: Life Year Gained (LYG) to be calculated using the EQ-5D, total costs during hospitalization, and health care utilization for 1 year after discharge.
Measure: Cost Effectiveness Analysis Time: 365 daysChest radiography is the gold standard for confirming tracheal intubation. Bedside ultrasound can be a useful alternative. The investigators are conducting a multi-center, observational study from January 2019 to May 2020 (COVID-US Study) to determine the feasibility of tracheal and lung ultrasound in confirming endotracheal tube placement in the critically ill.
Description: Adequate endotracheal tube position in agreement with chest radiograph
Measure: Concordance with next occurring chest radiograph Time: within 24 hoursDescription: Number of esophageal intubations detected during intubation attempt
Measure: Esophageal Intubation detection Time: within intubation attemptDescription: Number of right main stem intubations detected with ultrasonography
Measure: Right main or endobronchial intubation Time: within intubation attemptDisproportionate impact of COVID-19 in patients with obesity is now well established. Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19. The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.
Description: number of fatal cases
Measure: ICU mortality Time: through study completion, an average of 14 daysDescription: number of patients with invasive mechanical ventilation
Measure: Invasive mechanical ventilation Time: through study completion, an average of 14 daysDescription: number of fatal cases
Measure: In-hospital mortality Time: through study completion, an average of 21 daysTo limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period.
Description: Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed 3 months after the ICU discharge of patient. HADS ranges from 0 to 42; higher scores indicate worse symptoms.
Measure: Anxiety Time: at 3 monthsDescription: Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed 3 months after the ICU discharge of patient. HADS ranges from 0 to 42; higher scores indicate worse symptoms.
Measure: Depression Time: at 3 monthsDescription: Impact of post traumatic stress disorder for relative of ICU patient will be measured with the Event scale revised (IES-R) assessed 3 months after the ICU discharge of patient. IES-R ranges from 0 to 88; higher scores indicate worse symptoms
Measure: post-traumatic stress disorder Time: at 3 monthsSince early 2020, France knows a sanitary crisis with a massive influx of COVID-19 patients admitted in Intensive Care Units (ICU). It led to a saturation of the French health system, especially in some geographic areas such as East of France or Paris region. Therefore, authorities decided to transfer some critically ill patients from these crowded ICUs to less busy regional ICUs. it was done for the first time by medical train transportation. Knowing that the investigators lack experience regarding this type of medical evacuation, regarding the high number of transferred patients, with such a logistic effort, the investigators decided to study this phase of the COVID-19 sanitary crisis in order to draw a feedback. So far, there are no data in the literature regarding this topic.
Description: to evaluate mortality
Measure: number of death Time: at Intensive Care Units discharge, an average of 1 monthsDescription: to evaluate morbidity
Measure: number of infections Time: from date of admission until Intensive Care Units discharge, assessed up to 1 monthsThe primary aim of this study is to evaluate the effect of physical rehabilitation performed in intensive care unit on the range of joint motions and muscle strength of survivors following discharge from intensive care unit in patients with COVID-19. Secondary outcome is to assess the duration of mechanical ventilation, length of stay in intensive care unit and in hospital, and mortality rates during intensive care unit stay and health related quality of life following discharge in survivors. Until April 14 patients were provided all the intensive care managements except for rehabilitation and patients discharged before this time constituted the 'non-rehabilitation' group (n=17). Patients discharged after April 14 were provided rehabilitation in addition to usual intensive care unit care and constituted the study 'rehabilitation' group (n=18). Passive range of motion exercises to each joint and neuromuscular electrical stimulation to bilateral quadriceps and tibialis anterior muscles were applied 6 days/week in the 'rehabilitation' group during intensive care unit stay.
Description: Hand grip strength is an indicator of overall muscle strength that predicts mortality in older patients. Handgrip strength was measured using a handheld dynamometer according to the instructions of the American Society of Hand Therapists.Patients were seated placing their arms by their sides with the elbow flexed to 90°, the forearm mid-prone, and the wrist in neutral position. Patients were asked to grip the dynamometer with maximal effort using standard verbal encouragement. Three trials were performed in the dominant hand with a 30 sec rest between trials and the highest value was recorded in kg. The cut-off values of grip strength is 28.6 kg in men and 16.4 kg in women. The measurement was performed 1 month after discharge.
Measure: Hand grip strength Time: 1 month after discharge from hospitalDescription: Short form - 36 measures health related quality of life. It is a self-reported survey that evaluates individual health status with eight parameters consisting of physical function, pain, role limitations attributed to physical problems, role limitations attributed to emotional problems, mental health, social functioning, energy/ vitality, general health perception. There is not a summary score, each section is scored between 0-100, 0 indicates the worst condition, 100 indicates the best. The measurement was performed 1 month after discharge.
Measure: Short form - 36 Time: 1 month after discharge from hospitalDescription: Number of days of stay in intensive care unit from admission to discharge
Measure: Length of stay in intensive care unit Time: through study completion, an average of 3 monthsDescription: Number of days of stay in hospital from admission to hospital to discharge from hospital
Measure: Length of stay in hospital Time: through study completion, an average of 3 monthsDescription: Number of days of invasive mechanical ventilation during intensive care unit
Measure: Duration of invasive mechanical ventilation Time: through study completion, an average of 3 monthsDescription: Manual muscle strength was graded via a composite of Medical Research Council Scale score which has an excellent inter-rater reliability in survivors of critical illness. This scale range from 0 point (no muscle contraction) to 5 points (normal muscle strength). Through examination of 3 muscle groups in each limb (arm abduction, forearm flexion, wrist extension, hip flexion, knee extension and ankle dorsiflexion), clinical important muscle weakness has been defined as a composite score < 48 out of maximum 60 points. The measurement was performed 1 month after discharge.
Measure: Manual muscle strength Time: 1 month after discharge from hospitalDescription: Range of joint motion was evaluated in upper and lower extremity joints by physical examination and the results were recorded as normal or restricted for each joint. The measurement was performed 1 month after discharge.
Measure: Range of joint motion Time: 1 month after discharge from hospitalOut of 49 early-stage critically-ill COVID-19 patients, 21 patients are the experimental group who take convalescent plasma compared to 28 patients receive only conventional therapy without taking Convalescent plasma. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease are monitored in relation to monitoring through severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) RNA detection via poly chain reaction (PCR), and SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) serological monitoring.
Description: evaluate the role of convalescent plasma in saving life of treated patients by measuring the final outcome whether treated patients survived or died
Measure: Death versus survival of treated patients Time: Up to 8 weeksDescription: this outcome is about measuring the length of stay (in days) of treated patients with convalescent plasma versus tose who were treated with conventional therapies
Measure: The length of stay in hospitals Time: Up to 8 weeksThe aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies.
Description: As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria
Measure: Incidence of any stage of acute kidney injury Time: 14 daysDescription: Mortality
Measure: Mortality Time: 14-day, hospital, and intensive care unit (ICU) mortalityDescription: Defined by return of creatinine to < 1.5 times of baseline
Measure: Renal recovery Time: 14 daysDescription: Percentage
Measure: Percentage of patients who receive renal replacement therapy Time: 14 daysDescription: Percentage of participants who are dialysis dependent
Measure: Percentage of participants who are dialysis dependent Time: Through study completion, an average of 90 daysDescription: Days without vasoactive medications and mechanical ventilation
Measure: Free-days of vasoactive medications and mechanical ventilation Time: Day 30Description: Length of intensive care unit and hospital stay
Measure: Length of intensive care unit and hospital stay Time: Through study completion, an average of 90 daysDescription: Congestive heart failure, Arrhythmia, Acute respiratory distress syndrome, Septic shock, Acute cardiac injury, pneumonia
Measure: Number of participants with consequences following AKI Time: Through study completion, an average of 90 daysDescription: Time from illness onset to need for mechanical ventilator support
Measure: Time from illness onset to need for mechanical ventilator support Time: Through study completion, an average of 30 daysThe study is devoted to the comparative analysis of the data received in patients with COVID-19 lung pathology using the method of probe-based confocal laser endomicroscopy of distal airways and two reference methods: high resolution computed tomography and morphology (in some patients).
Description: pCLE images are assessed morphometrically. Such criteria as quantity of alveolar macrophages, quantity of floating intraalveolar substances etc. are measured using a 6-point score, where zero means the absence of the symptom and 5 means the maximal expressiveness. Thickness of interalveolar septum, diameter of microvessels and thickness of elastic fibers are measured using a special tool with the included software for the endomicroscopic system. Radiologic signs e.g. low-density areas and consolidation areas are assessed in Hounsfield Units. Other radiologic signs e.g. groundglass opacity, crazy paving patterns etc. are measured by a 5-point scale, where zero means the absence of the symptom and 4 means the maximal expressiveness. The morphological analysis of the lung tissue specimens (received as a result of autopsy/transbronchial biopsy) is made according to the structures in pCLE images for 20 fields of view.
Measure: Number of COVID-19 Participants With Notable Differences in the pCLE images in comparison with the pCLE images of non-COVID-19 Participants Time: up to one yearDescription: pCLE images are assessed morphometrically. Such criteria as quantity of alveolar macrophages, quantity of floating intraalveolar substances etc. are measured using a 6-point score, where zero means the absence of the symptom and 5 means the maximal expressiveness. Thickness of interalveolar septum, diameter of microvessels and thickness of elastic fibers are measured using a special tool with the included software for the endomicroscopic system. Radiologic signs e.g. low-density areas and consolidation areas are assessed in Hounsfield Units. Other radiologic signs e.g. groundglass opacity, crazy paving patterns etc. are measured by a 5-point scale, where zero means the absence of the symptom and 4 means the maximal expressiveness. The morphological analysis of the lung tissue specimens (received as a result of autopsy/transbronchial biopsy) is made according to the structures in pCLE images for 20 fields of view.
Measure: Number of Participants With the Correspondence of pCLE Images to High Resolution Computer Tomography and Morphologic Data as a Measure of Specificity and Sensitivity of the Method Time: up to one yearThis case series describes the clinical characteristics, treatment and outcomes of patients with laboratory confirmed COVID-19 admitted to a 35 beds intensive care unit of a tertiary hospital in Northeast Brazil.
Description: A seven-category ordinal scale consisting of: 1. Death; 2. hospitalized, on invasive mechanical ventilation; 3. hospitalized, on non-invasive ventilation; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized not requiring supplemental oxygen; 6. hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. 7 Not hospitalized
Measure: Outcome 30 days after ICU admission Time: 30 days after admissionPrimary objective is to evaluate the feasibility of delivering an online early Eye Movement Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who have survived Covid-19 related critical illness, within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in reducing psychological symptoms, for adult survivors of intensive care.
Description: Feasibility will be determined by the following measures: Able to recruit >30% of eligible patients approached Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention. Protocol adherence Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility. Outcome measures completed in 75% or more of trial participants
Measure: Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints Time: 12 monthsDescription: The PTSD Checklist-Civilian Version (PCL-C) is a validated, standardised self-reporting questionnaire for PTSD comprising of 17 items that correspond to key PTSD symptoms
Measure: Post-Traumatic stress disorder Time: 6 months post-hospital dischargeDescription: Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-reported measure with 7-items relating to symptoms of anxiety and 7-items relating to depression
Measure: Anxiety and depression Time: 6 monthsDescription: Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment
Measure: Cognitive function Time: 6 months post-hospital dischargeDescription: EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.
Measure: Health Related Quality of Life Time: 6 months post-hospital dischargeDescription: WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles
Measure: Health and disability Time: 6 months post-hospital dischargeDescription: Wrist worn physical activity monitoring
Measure: Physical activity Time: 6 months post-hospital dischargeDescription: Patient generated subjective global assessment
Measure: Nutritional status Time: 6 months post-hospital dischargeNovel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global health emergency since it was first detected in Wuhan, the People Republic of China in December 2019. Since then, the prevalence has rapidly increased worldwide. In Indonesia, by the end of April 2020, around 10,000 patients have been tested positive for Covid-19 infection, with a case fatality rate of around 8%. The pathogenesis of Covid-19 is still under investigation and to our understanding, ACE2 receptors in the alveoli serve as the binding site of the S-protein of envelope spike virus of SARS-CoV-2. TMPRSS2 enzyme aids the fusion between cell membrane and capsid of the virus, allowing penetration of virus into the cell. Vesicles containing virion fuse with cell membrane and released as new virions. Cytopathic effect of the virus and its ability to overcome immune response determines the degree of infection. Differences in immunological profile among degrees of severity of Covid-19 may vary especially for the number of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α), interleukin (IL)-1, IL-6, IL-8, leukemia-inhibiting factors (LIF), immunological markers such as CXCR3+CD4+, CXCR3+CD8+ T cell and CXCR3+ NK cells, implying the ongoing cytokine storm. The previous studies also found increasing number for infection markers such as procalcitonin, ferritin, and C-reactive protein. The decreasing number of anti-inflammatory cytokines in such as IL-10 also supports this finding. Previous studies have shown immunomodulating and anti-inflammatory capacity of the mesenchymal stem cells (MSCs). MSCs contributed to the shifting of pro-inflammatory Th2 into anti-inflammatory Th2. One of the most recent study on the usage of MSCs on Covid-19 patients showed increased expression of leukemia inhibitory factor (LIF), which give rise to inhibitory effect of T lymphocyte and natural killer (NK) cell population. Vascular epithelial growth factor (VEGF) is found increasing following MSCs administration, which indicates the ability to improve the disrupted capillaries due to SARS-Cov-2 infection. The ability of MSCs in differentiating to alveolar cells is proven by the presence of SPM and SPC2, surfactant proteins produced by type II alveolar cells. MSCs are unable to be infected by SARS-CoV-2 since they don't have ACE2 receptors and TMPRSS2 enzyme.
Description: Assessing whether the patients still have dyspnea, one of cardinal symptoms of Covid-19, assessed from the respiratory rate
Measure: Clinical improvement: Presence of dyspnea Time: 15 daysDescription: Assessing whether the patients still have productive cough, one of cardinal symptoms of Covid-19, assessed from lung auscultation
Measure: Clinical improvement: presence of sputum Time: 15 daysDescription: Assessing the presence of fever from measurement of body temperature checking, assessed on daily basis
Measure: Clinical improvement: fever Time: 15 daysDescription: Assessing whether the patients still require ventilation, one of cardinal symptoms of ARDS in Covid-19, assessed from patients' ability during ventilation weaning phase
Measure: Clinical improvement: ventilation status Time: 15 daysDescription: Assessing the patients' blood pressure on daily basis
Measure: Clinical improvement: blood pressure Time: 15 daysDescription: Assessing the patients' heart rate on daily basis
Measure: Clinical improvement: heart rate Time: 15 daysDescription: Assessing the patients' respiratory rate on daily basis
Measure: Clinical improvement: respiratory rate Time: 15 daysDescription: Assessing the patients' oxygen saturation on daily basis
Measure: Clinical improvement: oxygen saturation Time: 15 daysDescription: Assessing the changes in total leukocyte upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from leukocyte level Time: 15 daysDescription: Assessing the changes in lymphocytes level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from lymphocytes level Time: 15 daysDescription: Assessing the changes in blood pH level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood pH Time: 15 daysDescription: Assessing the changes in blood pH level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood level of CO2 Time: 15 daysDescription: Assessing the changes in blood base excess level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood base excess level Time: 15 daysDescription: Assessing the changes in blood oxygen partial pressure upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood oxygen partial pressure Time: 15 daysDescription: Assessing the changes in blood level of HCO3 upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood level of HCO3 Time: 15 daysDescription: Assessing the changes in blood level of O2 saturation upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood level of O2 saturation Time: 15 daysDescription: Assessing the changes in level of CRP, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from level of CRP Time: 15 daysDescription: Assessing the changes in laboratory parameter, consist of SGOT/SGPT (AST/ALT) level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from level of SGOT/SGPT (AST/ALT) Time: 15 daysDescription: Assessing the changes in laboratory parameter, consist of ureum/creatinine level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of ureum/creatinine level Time: 15 daysDescription: Assessing the changes in laboratory parameter, consist of eGFR, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of eGFR Time: 15 daysDescription: Assessing the changes in level of sodium, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of sodium Time: 15 daysDescription: Assessing the changes in level of potassium, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of potassium Time: 15 daysDescription: Assessing the changes in level of chloride, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of chloride Time: 15 daysDescription: Assessing the changes in procalcitonin level to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Changes in procalcitonin level Time: 15 daysDescription: Assessing the changes in albumin level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from albumin level Time: 15 daysDescription: Assessing the changes in total bilirubin level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from total bilirubin level Time: 15 daysDescription: Assessing the changes in D-Dimer to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Changes in D-Dimer level Time: 15 daysDescription: Assessing the changes in fibrinogen to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Changes in fibrinogen level Time: 15 daysDescription: Assessing the changes in troponin level to assess the anti-inflammatory properties of MSCs and their effect in cardiac remodelling, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Cardiac changes from troponin level Time: 15 daysDescription: Assessing the changes in NT proBNP to assess the anti-inflammatory properties of MSCs and their effect in cardiac remodelling, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Cardiac changes from NT proBNP level Time: 15 daysDescription: Assessing the changes in leukemia inhibiting factor (LIF) to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in Leukemia Inhibiting Factor Time: 7 daysDescription: Assessing the changes in level of IL-6 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of IL-6 Time: 7 daysDescription: Assessing the changes in level of IL-10 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of IL-10 Time: 7 daysDescription: Assessing the changes in vascular endothelial growth factor (VEGF) to assess the effect of growth factors in the MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of vascular endothelial growth factor (VEGF) Time: 7 daysDescription: Assessing the changes in level of ferritin to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of ferritin Time: 7 daysDescription: Assessing the changes in level of CXCR3 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of CXCR3 Time: 7 daysDescription: Assessing the changes in level of CD4 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of CD4 Time: 7 daysDescription: Assessing the changes in level of CD8 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of CD8 Time: 7 daysDescription: Assessing the changes in CD56 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of CD56 Time: 7 daysDescription: Assessing the changes in radiology examination (Chest X-Ray/CT Scan) for any increased in lung infiltration or ground glass opacity, assessed prior to implantation and once every 3 days post-implantation
Measure: Radiologic Improvement from Chest X-Ray/CT Scan Time: 15 daysThis is a registry-based cohort study of all adult patients (≥18 years) admitted to Swedish Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the first 2 months of the 2020 pandemic. The main goal is to describe demographic characteristics, coexisting conditions, treatments and outcomes among critically ill patients with COVID-19. A secondary goal is to identify independent risk factors associated with increased mortality for these patients. Data regarding baseline characteristics including comorbidities, intensive care treatments and outcomes will be extracted. ICU lengths of stay and 30-day mortalities will be calculated. The primary outcome was 30-day all-cause mortality
Description: all-cause
Measure: 30-day mortality Time: 30 daysDescription: all cause
Measure: ICU mortality Time: 30 daysCOVID19 is n outbreak with unpredictable outcome
Description: measurements of arterial blood gas
Measure: clinical characteristics Time: 48 hoursThe COVID-19 pandemic has led to shortages of intravenous sedatives due to increased ICU patient admissions and greater use of mechanical ventilation. A shortage of sedatives is as concerning as a shortage of mechanical ventilators since critically ill patients require sedation for comfort and to tolerate mechanical ventilation. Anti-adrenergic medications are increasingly recognized for their role in sedation of critically ill patients. Propranolol is a plentiful and inexpensive, non-selective beta-adrenergic blocker with good penetration of the blood-brain barrier, which can reduce agitation and arousal. The study team published a single-centre retrospective study of 64 mechanically-ventilated patients which found the initiation of propranolol was associated with an 86% reduction in propofol dose and a roughly 50% reduction in midazolam dose while maintaining the same level of sedation. Propranolol has the potential to mitigate the threat posed by worldwide sedative shortages and improve critical care management of patients who require mechanical ventilation. This study seeks to evaluate whether the addition of propranolol to a standard sedation regimen reduces the dose of sedative needed in critically ill patients requiring mechanical ventilation. This study is an open-label randomized controlled trial, single-blinded with 1:1 allocation. Both arms will receive sedation according to usual intensive care unit practice with a sedative agent. The intervention arm will additionally receive enteral propranolol 20-60mg q6h titrated up over 24-48h until intravenous sedative doses have fallen to a minimal level (propofol <0.5mg/kg/h or midazolam <0.5mg/h) or the maximum dose of propranolol is reached. Intravenous sedative doses will be titrated downwards in response to sympatholysis produced by the propranolol, as evidenced by a decreasing heart rate or blood pressure. The control arm will receive sedation without the addition or propranolol. The primary outcome will be the change in primary sedative dose from baseline to Day 3 of enrollment. Analysis of the primary outcome will be a difference in differences; the change in sedative dose from baseline to Day 3 in the intervention group versus the same change in the control group. The Mann-Whitney U test will be used as a nonparametric test of independent samples for this outcome.
Description: Change from baseline in total daily dose of primary sedative on Day 3
Measure: Primary sedative dose change Time: 24 hours prior to enrollment to Day 3 of the study (60-84hrs after enrollment)Description: Proportion of measured sedation scores within target range (to be defined a priori by treating team): Richmond Agitation-Sedation Scale and/or the Sedation-Agitation Scale
Measure: Sedation scores Time: Daily upon enrollment until study completion (discharge from ICU, 28 days, or death - whichever is first)Description: Proportion of participants whose sedative dose on day 3 are below a minimum level (propofol <0.5mg/kg/h or midazolam <1.9mg/h)
Measure: Primary sedative dose Time: Day 3 of study (60-84hrs after enrollment)Description: Change from baseline in total daily dose of all sedatives (in mg of midazolam equivalents) on Day 3
Measure: Total sedative daily dose change Time: 24 hours prior to enrollment to Day 3 of the study (60-84hrs after enrollment)Description: Change from baseline in total daily dose of all opioids (in mcg of fentanyl equivalents) on Day 3
Measure: Total opioid daily dose change Time: 24 hours prior to enrollment to Day 3 of the study (60-84hrs after enrollment)Description: Incidence of bradycardia (HR <50 or requiring intervention)
Measure: Adverse event - bradycardia Time: Daily from study enrollment until study completion (discharge from ICU, 28 days, or death - whichever is first)Description: Incidence of hypotension (MAP <60 requiring new vasopressor agents or an increase of >0.1 mcg/kg/min of norepinephrine or epinephrine persisting more than 2h after reducing sedative doses)
Measure: Adverse event - hypotension Time: Daily from study enrollment until study completion (discharge from ICU, 28 days, or death - whichever is first)Description: Incidence of clinically-important bronchospasm requiring a change in mechanical ventilation settings
Measure: Adverse event - bronchospasm Time: Daily from study enrollment until study completion (discharge from ICU, 28 days, or death - whichever is first)Description: Incidence of new ECG conduction delays
Measure: Adverse event - ECG conduction delays Time: Daily from study enrollment until study completion (discharge from ICU, 28 days, or death - whichever is first)Description: Total number of days of propranolol use
Measure: Duration of propranolol use Time: Daily from enrollment to study withdrawal/completion (last day of propranolol dose given; discharge from ICU, 28 days, or death - whichever is first)Description: Mean propranolol dose on day 3
Measure: Propranolol dose Time: Day 3 of study (60-84hrs after enrollment)Description: Mean number of ventilator-free days in first 30 days of hospital intensive care unit admission
Measure: Ventilator-free days Time: Day 1 of admission to the intensive care unit until 30 days, discharge from intensive care, or death (whichever is first)Description: Mean number of delirium-free days in first 30 days of hospital intensive care unit admission, measured using the Intensive Care Delirium Screening Checklist
Measure: Delirium-free days Time: Day 1 of admission to the intensive care unit until 30 days, discharge from intensive care, or death (whichever is first)Description: Mean length of stay in hospital
Measure: Hospital Length of Stay Time: Day 1 of hospital admission until hospital discharge date or date of death (whichever is first)Description: Mean length of stay in the intensive care unit
Measure: Intensive Care Unit Length of Stay Time: Day 1 of intensive care unit admission until discharge date from intensive care unit or date of death (whichever is first)Description: Mortality rate among participants while in hospital
Measure: Hospital Mortality Time: Upon study completion (after all 108 participants have completed the study, estimated at 6 months) and after 50 patients have been enrolled (estimated at 3 months)Description: Mean cost of sedative medication used in the intensive care unit among the intervention and control arms
Measure: Direct Costs Time: Upon study completion (after all 108 participants have completed the study, estimated at 6 months)This study is to analyze the microglia reaction or direct neurotropic effects of CNS COVID-19 in pathogenesis and brain stem dysfunction in critically ill patients. A microglia-focused, brain-specific 50+ marker CODEX panel is used to assess the neuroinflammatory microenvironment in specific brain regions of deceased COVID-19 patients. The peripheral (cerebrospinal fluid and peripheral blood) cytokine response to SARS-CoV-2 is investigated in regard to CNS affection and consecutive blood brain barrier disruption leading to braininherent neuroinflammatory reactions
Description: Comparison of lesions from patients that are neurologically affected to non-affected individuals in terms of CNS involvement to describe encephalitic changes due to COVID-19 infection.
Measure: MRI imaging data Time: Project duration for each patient takes 1 hour for the MRI at baselineDescription: Description of proteomic biomarkers (CSF and Plasma) in comparison with control reference sample.
Measure: Proteomic analysis Time: 10 minutes for blood draw at baselineDescription: Mass cytometry will be performed form peripheral blood mononuclear cells to count cell population frequency.
Measure: Peripheral blood leukocyte Cytof Mass Cytometry Analysis for cell population frequency Time: 10 minutes for blood draw at baselineDescription: In situ distribution assessment of marker expression (CD147 protein, ACE2 protein, Transmembrane protease serine subtype 2 (TMPRSS2))
Measure: CODEX (high dimensional microscopy) workflow analysis of defined regions on brain autopsy specimens Time: at baselineNovel coronavirus (SARS-CoV-2: severe acute respiratory coronavirus 2) pneumonia often develop the acute respiratory distress syndrome (ARDS). Lung protective ventilation strategy consisting of low tidal volume and high positive end-expiratory pressure (PEEP) is recommended. However, it is not clear whether injured lungs from SARS-CoV-2 pneumonia have the same mechanical properties, especially response to PEEP as common ARDS. Therefore, the investigators propose an observational study to analyze respiratory mechanics and lung recruitablity using EIT (electrical impedance tomography) in patients with ARDS due to SARS-CoV-2 pneumonia.
Description: The distribution of ventilation measured by EIT at PEEP 5 and 15.
Measure: The distribution of ventilation Time: Through study completion (up to 24 hours)Description: The changes in dependent and non-dependent silent spaces measured by EIT in PEEP 5 and 15.
Measure: Silent spaces Time: Through study completion (up to 24 hours)Description: Respiratory system compliance in PEEP 5 and 15.
Measure: Respiratory system compliance Time: Through study completion (up to 24 hours)Description: Oxygenation in PEEP 5 and 15.
Measure: Oxygenation Time: Through study completion (up to 24 hours)Description: Dead space ventilation ratio in PEEP 5 and 15.
Measure: Dead space ventilation ratio Time: Through study completion (up to 24 hours)The investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU day 5 until ICU discharge up to ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.
Description: Mortality 90 days post randomization
Measure: 90 day-all cause mortality Time: 90 daysDescription: use of vasopressor/inotropic support, invasive mechanical ventilation and/or renal replacement therapy
Measure: Days alive at day 90 without life support Time: 90 daysDescription: 90 day survival after randomization
Measure: Days alive and out of hospital at day 90 Time: 90 daysDescription: Any symptoms of bacteremia
Measure: Bacteremia until 2 days of ICU stay Time: until 2 days post ICU.Description: anytime during ICU stay
Measure: New or progression of Skin Pressure Ulcers Time: ICU stayDescription: SARC-F screen for sarcopenia and EuroQoL
Measure: Functional assessment at day 90 Time: Day 90Description: New episode of stage 2 or higher AKI by KDIGO criteria; 2. Pneumonia defined as episodes of newly confirmed pneumonia according to the modified CDC criteria; 3. Grade IV Acute Gastrointestinal injury (AGI)
Measure: Safety outcomes during ICU stay Time: ICU stayDescription: Feeding tolerance; Diarrhoea; Refeeding syndrome
Measure: Minor safety outcomes during ICU stay Time: ICU stay