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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug122 | AN69-Oxiris Wiki | 0.19 |
| drug2545 | Medical Record Review Wiki | 0.19 |
| drug2000 | Hydroxychloroquine/Azithromycine Wiki | 0.19 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug70 | 5-ALA-Phosphate + SFC (5-ALA + SFC) Wiki | 0.19 |
| drug107 | ACT-541478 high or low dose (or placebo) Wiki | 0.19 |
| drug89 | ABTL0812 Wiki | 0.19 |
| drug110 | ADM03820 Wiki | 0.19 |
| drug82 | A short video intervention Wiki | 0.19 |
| drug139 | ARFC mask Wiki | 0.19 |
| drug105 | ACT-541478 300 mg Wiki | 0.19 |
| drug1698 | Folfirinox Wiki | 0.19 |
| drug136 | ARCT-021 Dose Regimen 1 Wiki | 0.19 |
| drug60 | 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients) Wiki | 0.19 |
| drug148 | ASTX660 Wiki | 0.19 |
| drug4197 | Suramin Wiki | 0.19 |
| drug212 | Acknowledgement Racial Injustice AMA Wiki | 0.19 |
| drug106 | ACT-541478 dose E1 Wiki | 0.19 |
| drug149 | AT-001 Wiki | 0.19 |
| drug4024 | Sodium bicarbonate Wiki | 0.19 |
| drug83 | A vignette intervention Wiki | 0.19 |
| drug132 | ARCT-021 Dose 1 Wiki | 0.19 |
| drug4688 | VitalTalk communication skills training Wiki | 0.19 |
| drug3799 | SBI-101 Wiki | 0.19 |
| drug5214 | serum NGAL and cystatin c Wiki | 0.19 |
| drug353 | Any drug used to treat Covid-19 Wiki | 0.19 |
| drug3516 | Quinquina-Stevia/Azythromycin Wiki | 0.19 |
| drug77 | 68Ga-DX600 PET/CT Wiki | 0.19 |
| drug152 | ATAFENOVIR 200 MG KAPSUL Wiki | 0.19 |
| drug97 | ACP Decisions Video Program Wiki | 0.19 |
| drug140 | ARGX-117 Wiki | 0.19 |
| drug137 | ARCT-021 Dose Regimen 2 Wiki | 0.19 |
| drug61 | 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients ) Wiki | 0.19 |
| drug134 | ARCT-021 Dose 3 Wiki | 0.19 |
| drug3563 | Racial Inequality Highlighted Wiki | 0.19 |
| drug3047 | PHQ-9 Depression Scale Wiki | 0.19 |
| drug4806 | [TIMP-2]*[IGFBP-7] Wiki | 0.19 |
| drug4811 | acute kidney injury Wiki | 0.19 |
| drug98 | ACT-1014-6470 Wiki | 0.19 |
| drug123 | AN69-Standard Wiki | 0.19 |
| drug3280 | Placebo videos Wiki | 0.19 |
| drug4747 | White Sender in Informational Videos Wiki | 0.19 |
| drug63 | 38-questions questionnaire Wiki | 0.19 |
| drug129 | ARBIDOL 100 MG KAPSUL Wiki | 0.19 |
| drug124 | ANNE One Wiki | 0.19 |
| drug2825 | No Racial Inequality Highlighting Wiki | 0.19 |
| drug101 | ACT-541478 10 mg Wiki | 0.19 |
| drug1728 | GAD-7 General anxiety disorder scale Wiki | 0.19 |
| drug1070 | Commercial membrane for Extracorporeal Blood Purification Therapy (EBPT) Wiki | 0.19 |
| drug3600 | Recombinant human alkaline phosphatase Wiki | 0.19 |
| drug3301 | Plasma expansion with Ringer's Acetate Wiki | 0.19 |
| drug5137 | placebo+rHuPH20 Wiki | 0.19 |
| drug145 | ASP2390 Wiki | 0.19 |
| drug2476 | MRI scans Wiki | 0.19 |
| drug141 | ARGX-117 + rHuPH20 Wiki | 0.19 |
| drug133 | ARCT-021 Dose 2 Wiki | 0.19 |
| drug96 | ACEIs Wiki | 0.19 |
| drug2292 | LSALT peptide Wiki | 0.19 |
| drug104 | ACT-541478 30 mg Wiki | 0.19 |
| drug3300 | Plasma exchange and convalescent plasma Wiki | 0.19 |
| drug2846 | Non interventional study Wiki | 0.19 |
| drug255 | African American Sender in Informational Videos. Wiki | 0.19 |
| drug84 | AAZ Covid-19 rapid test Wiki | 0.19 |
| drug135 | ARCT-021 Dose 4 Wiki | 0.19 |
| drug93 | ACE inhibitor, angiotensin receptor blocker Wiki | 0.19 |
| drug2184 | Intervention training: Wiki | 0.19 |
| drug69 | 4Plants/Azythromycin Wiki | 0.19 |
| drug4746 | White Sender in Acknowledgement Wiki | 0.19 |
| drug254 | African American Sender Acknowledgement Wiki | 0.19 |
| drug108 | ADAM Sensor Wiki | 0.19 |
| drug102 | ACT-541478 100 mg Wiki | 0.19 |
| drug640 | Blood Transfusion Wiki | 0.19 |
| drug103 | ACT-541478 1000 mg Wiki | 0.19 |
| drug120 | AMA Acknowledgement Drug Pricing Wiki | 0.19 |
| drug111 | AG0301-COVID19 Wiki | 0.13 |
| drug314 | Angiotensin II Wiki | 0.13 |
| drug1162 | Conventional treatment Wiki | 0.13 |
| drug5281 | unfractionated Heparin Wiki | 0.13 |
| drug59 | 300 mg of omega3-FA Wiki | 0.13 |
| drug65 | 3D Telemedicine Wiki | 0.11 |
| drug1276 | Deferoxamine Wiki | 0.11 |
| drug2229 | Itraconazole Wiki | 0.11 |
| drug112 | AG0302-COVID19 Wiki | 0.11 |
| drug3584 | Ravulizumab Wiki | 0.11 |
| drug2528 | Matching placebo Wiki | 0.09 |
| drug2615 | Midazolam Wiki | 0.08 |
| drug2827 | No intervention Wiki | 0.08 |
| drug2873 | Normal saline Wiki | 0.07 |
| drug3195 | Placebo Wiki | 0.07 |
| drug4102 | Standard of Care Wiki | 0.06 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D014947 | Wounds and Injuries NIH | 0.34 |
| D018746 | Systemic Inflammatory Response Syndrome NIH | 0.19 |
| D057049 | Thrombotic Microangiopathies NIH | 0.19 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007049 | Iatrogenic Disease NIH | 0.19 |
| D009102 | Multiple Organ Failure NIH | 0.15 |
| D018805 | Sepsis NIH | 0.12 |
| D012772 | Shock, Septic NIH | 0.11 |
| D007238 | Infarction NIH | 0.05 |
| D016638 | Critical Illness NIH | 0.04 |
| D009203 | Myocardial Ischemia NIH | 0.04 |
| D013577 | Syndrome NIH | 0.03 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.03 |
| D018352 | Coronavirus Infections NIH | 0.03 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.02 |
| D055371 | Acute Lung Injury NIH | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001919 | Acute kidney injury HPO | 1.00 |
| HP:0100806 | Sepsis HPO | 0.12 |
| HP:0001658 | Myocardial infarction HPO | 0.04 |
Navigate: Correlations HPO
There are 29 clinical trials
A study of renal blood flow and renal oxygenation measured by magnetic resonance after a standardized fluid challenge in critically ill, resuscitated, patients with sepsis due to COVID-19 or other agents.
Description: Measured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST), compared to baseline measurement
Measure: Change in renal blood flow and renal oxygenation after standardized plasma expansion with fluid bolus Time: When achieved according to protocol, approximately 3-10 minutes after interventionDescription: Measured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST) during baseline measurement.
Measure: Descriptive renal oxygenation and blood flow in critical illness due to sepsis Time: During Critical illness - at one time pointDescription: Measured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST) images stratified in groups in regards to KDIGO grade during exam.
Measure: Descriptive renal oxygenation and blood flow in critical illness in no/low grade AKI or high grade AKI. Time: During Critical illness - at one time pointThe goal of the proposed study is to determine whether a liberal transfusion strategy (transfusion trigger at Hb < 10 gm/dl) in Veterans at high cardiac risk who undergo major open vascular and general surgery operations is associated with decreased risk of adverse postoperative outcomes compared to a restrictive transfusion strategy (transfusion trigger at Hb < 7 gm/dl).
Description: MI will be defined using the Third Universal Definition of Myocardial Infarction. Acute renal failure will be defined as Acute Kidney Injury stage III according to RIFLE criteria. Baseline creatinine will be considered the creatinine upon admission prior to the index operation. The above urine output criteria will be only used for patients who are in the ICU and have precise monitoring of their urinary output. For patients on the surgical floor only serum creatinine changes will be used for assessment of this endpoint. Coronary revascularization will be defined as a coronary artery bypass graft, or percutaneous coronary intervention (either angioplasty or stenting). Stroke will be defined as new unilateral neurological deficit that lasts for more than 24 hours, and is confirmed by a brain imaging modality (computed tomography or magnetic resonance imaging study) demonstrating new brain infarct.
Measure: A composite endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization. Time: 90 days after randomizationDescription: Wound infection will be defined according to the Centers for Disease Control and Prevention (CDC) guidelines as a) positive wound culture, or b) drainage of pus from a wound, or c) suspicion of wound infection that was drained operatively. Pneumonia will be defined according to the CDC definition as chest radiograph with new or progressive infiltrate, consolidation, cavitation, or pleural effusion and any of the following: new onset of purulent sputum or change in character of sputum, or organism isolated from blood culture, trans-tracheal aspirate, bronchial brushings, or biopsy. Sepsis will be defined as a combination of two of the following systemic inflammatory response syndrome (SIRS) criteria, plus suspected or present source of infection. SIRS criteria will include the following: temperature greater than 38C, heart rate greater than 90 beats/min, WBC > 12,000 or < 4,000, or > 10% bands.
Measure: A composite endpoint of postoperative infectious complications at 90 days post-randomization: Infectious complications will include wound infections, pneumonia, and sepsis. Time: 90 days after randomizationDescription: The diagnosis of cardiac arrhythmias will be based on EKG findings. Only arrhythmias that result in initiation of new treatment regimen (to include medications, implantable devices, or surgical intervention) during hospitalization will be recorded. CHF will require at least one of the following symptoms or signs new or worsening: dyspnea at rest, orthopnea, or paroxysmal nocturnal dyspnea and radiological evidence of heart failure or worsening heart failure and increase/initiation of established treatment. Cardiac arrest will be defined as the cessation of cardiac pump function activity that results in loss of consciousness and absence of circulating blood flow as evidenced by absent carotid pulse. Only episodes of cardiac arrest that are reversed will be collected under this endpoint. If they are not reversed the event will be categorized as death.
Measure: A composite endpoint of cardiac complications (other than MI) at 90 days post-randomization: Cardiac complications will include new cardiac arrhythmias that necessitate new treatment, new or worsening congestive heart failure (CHF), and cardiac arrest no Time: 90 days after randomizationDescription: The investigators will determine vital status by telephoning participants after hospital discharge, by searching the electronic medical record and the National Death Index.
Measure: All-cause mortality at 1 year after randomization. Time: 12 months after randomizationDescription: MI, coronary revascularization, acute renal failure, or postoperative ischemic stroke.
Measure: A composite endpoint of all-cause mortality, Time: 30 days after randomizationDescription: Length of hospital stay
Measure: Length of hospital stay. Time: At hospital discharge, up to 1 yearDescription: All cause postoperative mortality, Postoperative MI, Postoperative coronary revascularization, Postoperative stroke,Postoperative acute renal failure
Measure: The investigators will examine individual rates of the outcomes that consist of individual components of the primary endpoint. Time: 90 days after randomizationThe outbreak of Covid-19 started several clinical trials and treatment experiments all over the world in the first months of 2020. This study investigates reports of adverse events related to used molecules, including but not limited to protease inhibitors (lopinavir/ritonavir), chloroquine, azithromycin, remdesivir and interferon beta-1a. Analyses of reports also include the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).
Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measure: Renal failure Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measure: Heart failure Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measure: EKG disturbance Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measure: Hepatic failure Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measure: Anemia Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measure: Leucopenia Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measure: Vascular disease Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measure: Toxidermia Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measure: Osteoarticular adverse event Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measure: Death Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measure: Acute respiratory distress syndrome Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measure: Pulmonary embolism or pulmonary hypertension Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020The kidney may be affected in coronavirus-2019 disease (COVID-19). This study assessed the predictors and outcomes of acute kidney injury (AKI) among individuals with COVID-19.
Description: the incidence of Acute Kidney Injury
Measure: Rate of Acute Kidney Injury Time: From date of admission until the date of discharge or death from any cause, up to 60 daysDescription: death from any cause in the hospital
Measure: Rate of Death Time: From date of admission until the date of death from any cause, up to 60 daysDescription: days from admission to discharge or death
Measure: the length of hospital stay Time: From date of admission until the date of discharge or death from any cause, up to 60 daysThe study aims to investigate organ dysfunction and biomarkers in patients with suspected or verified COVID-19 during intensive care at Uppsala University Hospital.
Description: KDIGO AKI score
Measure: Acute Kidney Injury Time: During Intensive Care, an estimated average of 10 days.Description: Acute Respiratory Distress Syndrome yes/no
Measure: ARDS Time: During intensive care, an estimated average of 10 days.Description: Death within 30 days of ICU admission
Measure: 30 day mortality Time: 30 daysDescription: Death within 1 year of ICU admission
Measure: 1 year mortality Time: 1 yearDescription: Development of Chronic Kidney Disease
Measure: Chronic Kidney Disease Time: 60 days and 1 year after ICU admissionDescription: Sequential Organ Failure Score as a continuous variable
Measure: SOFA-score Time: During Intensive Care, an estimated average of 10 days.Acute kidney injury (AKI) is reported to occur in 0.5-9% of severe acute respiratory distress coronavirus 2-positive patients and AKI has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of renal outcome of in-hospital patients diagnosed with COVID-19.
Description: As determined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Measure: Incidence of AKI Time: Within 7 days after admissionDescription: Serial biomarker assessment
Measure: Renal function changes during hospital stay Time: from hospital admission til discharge up to 3 monthsDescription: As determined by KDIGO criteria
Measure: Incidence of chronic kidney disease Time: 3 months post-hospital admissionIn this study, critically ill patients with highly suspected or confirmed COVID-19 will be included. Main goal is the identification of noncoding RNAs in COVID-19 associated organ dysfunction with an emphasis on acute kidney injury.
Among patients with SARS-CoV-2 pneumonia, approximately 20% have an acute kidney injury (AKI) and 5% require renal replacement therapy. Occurrence of AKI in patients with COVID-19 is associated with increased morbidity and mortality. Early detection of patients at risk of AKI would allow to prevent onset or worsening of AKI. The aim of this study is to determine if urine biomarkers of renal tubular damage such as TIMP-2 and IGFBP7 could early identify patients with SARS-CoV-2 pneumonia at risk of developing AKI.
Description: Sensibility and specificity of urinary [TIMP-2]*[IGFBP-7] > 0,3 to predict AKI (KDIGO stage ≥ 1) in SARS-CoV-2 patients at day-7 after measurement
Measure: Sensibility and specificity of urinary Time: Occurence of AKI 7 days after urinary biomarkers measurementDescription: Sensibility and specificity of urinary [TIMP-2]*[IGFBP-7] > 0,3 to predict AKI worsening, renal replacement therapy requirement or persistant AKI
Measure: Sensibility and specificity of urinary Time: Occurnce of AKI worsening, renal replacement therapy requirement or persistant AKI, 7 days after urinary biomarkers mesurementTo evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy (RRT) on Day 28. The need for continued RRT at Day 28 will be defined as either dialysis in the past 3 days (Day 26, 27, or 28) or an eGFR on Day 28 <10 mL/min/1.73 m2.
Description: To evaluate the efficacy of intravenous LSALT peptide plus standard of care to prevent the progression of COVID-19 to mild, moderate or severe ARDS, acute kidney injury, cardiomyopathy, acute liver injury, coagulopathy, or death in patients infected with SARS-CoV-2 compared with placebo plus standard of care.
Measure: Development of Acute Respiratory Distress Syndrome (ARDS) and Other Organ Injuries Time: 28 daysDescription: High-frequency oscillatory ventilation, with its rapid delivery of low tidal volumes and a respiratory rate in the range of 60 to 900 breaths/minute, has also been utilized in ARDS patients.
Measure: Ventilation-free days Time: 28 daysDescription: Oxygen therapy provided as non-invasive therapy for ARDS patients.
Measure: Time on nasal cannula or oxygen masks Time: 28 daysDescription: 28 day mortality - all cause and attributable
Measure: 28 day mortality - all cause and attributable Time: 28 daysDescription: ICU and hospitalization length of stay (days)
Measure: ICU and hospitalization length of stay (days) Time: 28 daysDescription: Swab (nasopharyngeal, nasal, throat, sputum, or lower respiratory tract) at baseline (Day 1) and every 3 days thereafter until eradication → virologic clearance rate
Measure: SARS-CoV2 testing Time: 28 daysDescription: Extracorporeal membrane oxygenation (ECMO) is often used for severe ARDS to allow lung healing/repair and reverse respiratory failure.
Measure: Need and duration for extracorporeal membrane oxygenation (ECMO) Time: 28 daysDescription: Vasopressor free days
Measure: Vasopressor free days Time: 28 daysDescription: Chest X-rays performed at Baseline, Day 3, at clinical improvement, and end-of-treatment (EOT) and study (EOS) to determine presence of bilateral opacities.
Measure: Radiographic pulmonary assessments Time: 28 daysDescription: Change in daily mMRC dyspnea and SOFA scores (0 to 4) with 4 being the most severe outcome
Measure: Change in modified Medical Research Council (mMRC) dyspnea and Sequential Organ Failure Assessment (SOFA) scores Time: 28 daysDescription: Incidence of other organ (non-lung) disorders
Measure: Incidence of non-lung disorders Time: 28 daysDescription: Change in liver function tests (ALT, AST, and total bilirubin levels) from baseline
Measure: Measures of liver dysfunction Time: 28 daysDescription: Change in SCr and eGFR from baseline
Measure: Measures of kidney dysfunction Time: 28 daysDescription: Change in highly-sensitive troponin (hs-troponin) from baseline
Measure: Measures of cardiac dysfunction Time: 28 daysDescription: Change from baseline ACT, aPTT, and/or PT/INR levels
Measure: Measures of coagulopathies Time: 28 daysDescription: Change in baseline antiviral immunoglobulins (IgG, IgM) at EOS.
Measure: Changes in immunogenic responses Time: 28 daysDescription: Changes in total healthcare costs from admission to discharge between treatment groups.
Measure: Healthcare outcomes Time: 28 daysDescription: Change in serum cytokines including IL-1α, IL-1ß, IL-1ra, IL-5, IL-6, IL-8, IL-12, TNFα, CXCL10/IP10, MCP-3, and ferritin drawn at the same time as LSALT peptide levels
Measure: Molecular changes in pro-inflammatory pathways Time: 28 daysDescription: Pharmacokinetics of LSALT peptide over the study period.
Measure: Pharmacokinetics of LSALT peptide Time: 28 daysThe two biomarkers determined in urine, "Tissue Inhibitor of Metalloproteinases 2 (TIMP-2)" and "Insulin-like Growth Factor-Binding Protein 7 (IGFBP7)", can indicate the occurrence of Acute kidney injury (AKI) in cardiac surgery and critically ill patients at an early stage. However, no data are available whether these parameters can also predict the occurrence of AKI in the context of COVID-19 infection. An early prediction of AKI can be helpful for the optimisation of therapeutic management to improve patient outcome and for the triage of patients. The aim of this observational study is to evaluate whether the biomarker [TIMP- 2]*[IGFBP7] can predict the occurrence of AKI in critically ill patients suffering from SARS-CoV2 associated acute respiratory distress syndrome.
Description: Occurence of moderate or severe AKI
Measure: Occurence of acute kidney injury (AKI) Time: within 7 days after beginning of moderate or severe ARDSDescription: e.g., Analysis of interleukin (IL) 6, IL8
Measure: Add-on analysis: pro- and antiinflammatory mediators Time: within 7 days after beginning of moderate or severe ARDSSevere Acute respiratory syndrome coronovirus (SARS-CoV-2) was first described in Wuhan in December 2019. It quickly spread to rest of the world and was declared pandemic by World health organisation. Initial case series focused on lung involvement in the form alveolar haemorrhages and respiratory failure. However, subsequently, there have been reports of kidney involvement resulting in severe acute kidney injury. However, the reported incidence from Chinese data has been less than 5% and detailed epidemiology of AKI in COVID-19 disease is lacking.
Description: This is the proportion of patients with Acute kidney injury in COVID-19
Measure: Incidence of Acute kidney injury in COVID-19 Time: 7 daysDescription: This is the number of deaths in COVID-19 AKI patients
Measure: All-cause mortality in AKI patients Time: 7 daysThis research aims to investigate the role of daily measurement of urinary cell cycle arrest markers and other serum and urinary biomarkers to predict the development of acute kidney injury in critically ill patients with COVID-19 and acute respiratory disease.
Description: As defined by Kidney Diseases: Improving Global Outcome
Measure: Any stage of acute kidney injury Time: 7 daysDescription: Renal replacement therapy requirement at the clinicians' discretion
Measure: need for RRT in first 7 days Time: 7 daysDescription: ICU mortality
Measure: Mortality Time: 7 and 28 daysDescription: Duration
Measure: Duration of mechanical ventilation Time: 7 and 28 daysDescription: Duration
Measure: Duration of vasopressor support Time: 7 and 28 daysClinical phase 3 study to investigate the effect of recAP on 28 day mortality in patients admitted to the ICU with acute kidney injury that is caused by sepsis. The study has three distinct SA-AKI trial populations: 1. The main trial population: Patients with a pre-AKI reference eGFR ≥45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization. 2. A 'moderate' CKD population: Patients with a pre-AKI reference eGFR ≥25 and <45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization. 3. A COVID-19 population: Patients with proven or suspected SARS-CoV-2 at time of randomization with or without 'moderate' CKD. In the main study population approximately 1400 patients will be enrolled and in the two cohorts with moderate CKD and COVID-19 each up to 100 patients. There are two arms in the study, one with active treatment and one with an inactive compound (placebo). Treatment is by 1 hour intravenous infusion, for three days. Patients are followed up for 28 days to see if there is an improvement on mortality, and followed for 90 and 180 days for mortality and other outcomes e.g. long-term kidney function and quality of life.
Description: To demonstrate an effect of recAP on 28 day all cause mortality
Measure: 28-day all-cause mortality Time: 28 daysDescription: MAKE 90: dead or on RRT or ≥25% decline in estimated glomerular filtration rate (eGFR) on Day 90 relative to the known or assumed pre-AKI reference level.
Measure: To investigate the effect of recAP on long-term Major Adverse Kidney Events (MAKE). Time: 90 DaysDescription: Days alive and free of organ support through Day 28, i.e., days alive with no MV, RRT, vasopressors or inotropes (with death within 28 days counting as zero days).
Measure: To investigate the effect of recAP on use of organ support, i.e., mechanical ventilation (MV), Renal Replacement Therapy (RRT), vasopressors or inotropes. Time: 28 daysDescription: Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).
Measure: To investigate the effect of recAP on length of stay (LOS) in ICU. Time: 28 daysDescription: Time to death through Day 90.
Measure: To investigate the effect of recAP on 90-day allcause mortality Time: 90 daysThe purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in COVID-19 subjects with Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.
The 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 actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has appeared to be more frequent and more severe than expected. Some data suggested a potential direct renal tropism of the virus, or undirect injury by "cytokine storm". The aims of this study are: 1. To describe incidence, severity and mortality associated with AKI during covid-19 infection in ICU 2. To identify specific risk factors for AKI 3. To explore pathophysiologic mechanism of AKI during COVID-19 infection
Description: AKI will be defined according with KDIGO guidelines: increase in creatinine of more than 1,5 fold compared to baseline Severe CVOID-19 infection is defined as 1/ confirm COVID-19 infection (by TDM and/or qRT-PCR) 2/ Requirement of ICU support during more than 72h
Measure: Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection Time: 7 monthsThis study is an observational registry of children with or suspected to have SARS CoV2 (COVID-19) admitted to pediatric intensive care units (PICU). This registry will help describe the prevalence, rate and severity of acute kidney injury (AKI) in children with Severe Acute Respiratory Syndrome Coronavirus-2(SARS CoV2) across the world. The registry will be developed using a point prevalence methodology and then full retrospective review. Once a week, from April through June 2020, data collection will occur in "real-time" to estimate a weekly point prevalence of AKI and renal replacement therapy (RRT). The operational definition of "patients under investigation" (PUIs) will be used to identify the denominator of patients to be studied. The PUIs will be cohorted into SARS CoV2 test positive, test negative, test pending, or test unavailable. The primary aim of this study is to deliver a global, objective data driven analysis of the burden of AKI in virus positive patients or patients under investigation (PUI) who are admitted to the pediatric intensive care unit.
Description: Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output
Measure: Acute Kidney Injury (AKI) Time: 14 daysDescription: Survival to ICU discharge or Day 14
Measure: Survival Time: 14 daysDescription: The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy
Measure: Rate of Extracorporeal Therapy Requirement Time: 14 daysDescription: >20% fluid overload as defined as the net fluid balance since ICU admission (in liters) divided by ICU admission weight
Measure: Fluid overload Time: Day of EnrollmentDescription: The exposure of enrolled patients to known nephrotoxic medications, including diuretics
Measure: Rate of nephrotoxic medication exposure Time: Day of EnrollmentSince the emergence of the new strain of betacoronavirus (SARS-CoV-2) and its important clinical repercussions, it has been described that patients with its associated pneumonia (COVID-19) have high rates of thrombotic events, including reduction in the dialyzers patency when undergoing renal replacement therapy. Several strategies for preventing the early loss of dialysers are described, and regional anticoagulation based on citrate is the preferred modality for preventing this complication. On the other hand, in patients with SARS-CoV-2 there are already descriptions of endothelial inflammation and activation of the coagulation cascade, including studies demonstrating the benefit of heparinization of these patients. Thus, this study aims to compare two different anticoagulation strategies in patients infected with COVID-19 with continued venovenous hemodialysis (CVVHD). From the indication of CVVHD, patients will be screened according to eligibility criteria and, if they fit these parameters, they will be randomized into two groups: Group A - Standard regional anticoagulation based on Citrate associated with infusion of low doses of unfractionated heparin 10ui/kg/hour and Group B - Standard regional anticoagulation based on Citrate only. Patients will be randomized in blocks and followed for 72 hours. The primary endpoint is dialyzer patency at the end of 72 hours of clinical follow-up. Secondary objectives will be mortality, bleeding rate, drop in hematimetric indices, urea sieving, filter time in hours, down time of therapy, system and dialyser pressures (PBE and PTM). All patients will undergo a standard procedure with a prescribed dose of 30mL/Kg/H, blood flow of 150mL/minute and polysulfone dialyzer.
Description: The percentage of clotted dialyzers within 72 hours in each of the studied groups.
Measure: Clotted dialyzers Time: Day 3 of dialysisDescription: Number of hours until a dialyzer clots in the first 72 hours of dialysis
Measure: Time-free of clotting Time: Day 3 of dialysisDescription: The amount of dialyzers used in the first 72 hours of hemodialysis
Measure: Number of dialyzers used Time: Day 3 of dialysisDescription: Variation in dialysis system and vascular access pressures in the first 72 h of dialysis
Measure: Pressure variation Time: Day 3 of dialysisDescription: Variation in urea sieving between the first, second and third days of dialysis
Measure: Urea sieving Time: Day 3 of dialysisDescription: Time of dialysis stop due to clotting in the first 72 hours
Measure: Downtime of dialysis Time: Day 3 of dialysisThis is a prospective, double-blind, randomized, placebo-controlled study to assess the effects of suramin as a potential treatment option to prevent subjects with AKI from progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III or dialysis dependent AKI.
Description: The difference between the effect of a 3.0 mg/kg infusion of suramin versus placebo will be based on meeting 2 or more of the composite event endpoints of: peak serum creatinine (Cr) of 6 mg/dL or above from investigational product (IP) infusion through Day or progression to KDIGO Stage III within 72 hours (hr) from IP infusion or death or dialysis from IP infusion through Day 7.
Measure: To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI Time: 7 daysOur overarching goal is to improve the outcomes of critically ill COVID-19 patients with or at risk for development of acute kidney injury (AKI). The objective of this study is to determine the role of a protocol to manage urine alkalization using a simple medication that has been used for a very long time, is safe, and without significant side-effects. We aim to determine the feasibility and safety of a urine alkalinization protocol for the prevention of AKI in patients testing positive for COVID-19.
Description: Primary feasibility outcome will be the proportion of patients treated who achieve >50% of urine measurements pH ≥= 7.2 over the duration of treatment.
Measure: pH Time: 10 daysDescription: Primary efficacy outcome will be the number of days alive and free of stage 2-3 AKI (up to 28) in each group.
Measure: Number of Days Alive Free of Stage 2-3 AKI Time: 28 days post-treatmentDescription: proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment).
Measure: Stage 2-3 AKI Time: 28 daysDescription: Ventilator-free days to 28 days
Measure: Vent-Free Time: 28 daysDescription: Hospital-free days to 60 days
Measure: Hospital-Free Time: 60 days post-index hospitalizationSeptic shock continues to exert a large economic burden around the world. Several developments have occurred that lead to the current study. First, angiotensin II is the newest FDA approved vasopressor agent indicated for use in vasodilatory shock. Several subgroups from the approval trial have indicated that angiotensin II may confer a survival benefit in certain conditions, including those patients requiring continuous renal replacement therapy, those with altered angiotensin I: angiotensin II ratios, and most recently, those with elevated renin levels (which may serve as a surrogate for dysfunctional angiotensin 1: angiotensin II ratios). This open-label, sequential period pilot study will evaluate angiotensin II and biomarker response (renin) in the treatment of septic shock.
Description: Plasma renin levels will be measured from blood collected at baseline, 24 hours, and at shock resolution. Additionally, a 3-hour measurement will be included in the angiotensin II arm.
Measure: Change in Plasma Renin Levels Time: Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)Description: Cystatin C, NGAL will be measured from blood collected at baseline, 24 hours, and at shock resolution.
Measure: Change in Renal Biomarkers Time: Until shock resolution, up to 14 days (at baseline, 24 hours, and shock resolution, up to 14 days)Description: Time from enrollment to discontinuation of catecholamines
Measure: Time to discontinuation of catecholamines Time: Until shock resolution, up to 14 daysDescription: Number of days in the intensive care unit (ICU).
Measure: ICU Length of Stay Time: From enrollment to ICU discharge, up to 28 days following enrollmentDescription: Assessment of all-cause mortality within hospital admission
Measure: In-hospital mortality Time: Up to 3 months following enrollmentDescription: Days free of renal replacement therapy from enrollment up to day 28
Measure: Renal replacement therapy-free days Time: Within 28 days of enrollmentDescription: Incidence of venous thromboembolism, arrhythmia, extremity hypoperfusion, delirium, new ischemic event, new infection
Measure: Safety outcomes Time: Up to 72 hours following shock resolution, no longer than 17 days from enrollmentUltomiris (Ravulizumab), is a monoclonal antibody that specifically targets terminal complement products and is proposed for the treatment of COVID-19 induced microvasculature injury and endothelial damage leading to thrombotic microangiopathy (TMA) causing acute kidney injury (AKI). Ravulizumab is to be used for participants with a confirmed diagnosis of COVID-19 who clinically or diagnostically present with deteriorating renal function. Ravulizumab causes immediate and sustained inhibition of the terminal complement cascade. The use of ravulizumab could ameliorate COVID-19 induced kidney injury due to TMA, shorten hospital stay, and improve the overall survival.
Description: 50% improvement in estimated glomerular filtration rate compared to conventional therapy within 30 days of treatment for COVID-19-induced acute kidney injury.
Measure: Assess the efficacy of ravulizumab to ameliorate SARS-CoV-2 (COVID-19)-induced acute kidney injury manifesting as thrombotic microangiopathy. Time: 30 daysDescription: Evaluation of pharmacokinetics of ravulizumab in participants with COVID-19 Changes in ravulizumab concentration in plasma
Measure: Evaluation of pharmacokinetics of ravulizumab in participants with COVID-19 Time: 120 daysThe COVID-19 pandemic has exposed the unwanted variation in outcomes as evidence by Public Health England's report on increased mortality in regions of the country. For example, UHDB, in East Midlands, has reported a high crude mortality as compared to other Trusts in the region.8 There may also have been variation in the incidence of complications of COVID-19 in the form of AKI, which may have influenced mortality. Variation in outcomes may be because of various factors - differing population demographics, underlying health conditions in the population, deprivation, physician preference and knowledge and ethnic diversity. Unwanted variation is care that is not consistent with a patient's preference or related to [their] underlying illness. It is important to understand the reason for unwanted variation in outcomes associated with COVID-19 to minimise patient harm and reduce morbidity and mortality.
Description: In-hospital all cause mortality in patients with acute kidney injury and COVID-19
Measure: All-cause mortality Time: 30 daysDescription: Incidence of acute kidney injury in patients with COVID-19
Measure: acute kidney injury Time: 30 daysDescription: Need for mechanical ventilation in patients with COVID-19
Measure: Mechanical ventilation Time: 30 daysWorldwide, the use of Extracorporeal Blood Purification (EBP) in everyday clinical practice is becoming increasingly common, particularly in critical care settings. The efficacy of most of these treatments on removal of inflammatory mediators is the main rationale behind the use of EBP in critically ill patients with multiorgan dysfunction. Nonetheless, there are still some doubts as to the clinical efficacy of bacterial toxins and cytokines removal and many clinical trials aiming at exploring the effect of EBP on long-term outcomes of septic patients have failed to demonstrate consistent results regarding 28 day- or hospital-mortality rates. The primary aim of this observational prospective web-based registry is to define the possible clusters of critically ill patients - treated with extracorporeal blood purification therapies worldwide - who are homogeneous regarding both clinical and treatment characteristics and seem to benefit the most from EBP.
Description: Define the possible clusters of critically ill patients - treated with extracorporeal blood purification therapies worldwide - that are homogeneous regarding both clinical and treatment characteristics thanks all the treatment and baseline clinical variables extracted from the patient Case Report Forms (CRFs).
Measure: Define the possible clusters of critically ill patients Time: 10 days after Extracorporeal Blood Purification Therapy (EBPT) initiationDescription: Define as ≥ 20% decrease in Vasoactive-Inotropic Score (VIS) at 48 hours with respect to baseline to assess the correlation between cluster membership and positive short-term outcome (i.e. an improvement in hemodynamic stability and inflammatory status).
Measure: To assess the correlation between cluster membership and positive short-term outcome. Time: 48 hours after EBPT initiationDescription: To assess the correlation between cluster membership and positive long-term outcome, defined as patient survival at ICU discharge.
Measure: To assess the correlation between cluster membership and positive long-term outcome. Time: 10 days after EBPT initiationDescription: To assess the correlation between positive short-term outcome and changes from baseline in clinical parameters and all treatment at 12 and 24 hours (as from the patient CRFs).
Measure: To assess the correlation between positive short-term outcome and changes from baseline. Time: 24 hours after EBPT initiationDescription: Timing of initiation of a specific Extracorporeal Blood Purification (EBT) treatment will be described.
Measure: To describe the clinical circumstances under which clinicians opt for specific techniques of extracorporeal blood purification therapy worldwide. Time: 10 days after EBPT initiationDescription: Absolute and relative frequencies of those clinical variables relevant to the application of a specific EBP treatment will be described.
Measure: To describe the clinical circumstances under which clinicians opt for specific techniques of extracorporeal blood purification therapy worldwide in terms of absolute and relative frequencies of clinical variables. Time: 10 days after EBPT initiationDescription: EBP utilization will be described in terms of cumulative incidence among all the enrolled patients from all participating centers
Measure: To describe EBP utilization rates in intensive care units worldwide. Time: 10 days after EBPT initiationDescription: EBP utilization will be described in terms of of yearly absolute frequencies and cumulative incidence among all the enrolled patients from all participating centers.
Measure: To describe EBP utilization rates in intensive care units worldwide in terms of absolute frequency Time: 10 days after EBPT initiationDescription: Utilization of Continuous Renal Replacement Therapy(CRRT), Intermittent Hemodialysis (IHD), and Hybrid Renal Replacement Therapies as well as of the different membranes will be described in terms of relative frequencies.
Measure: To describe EBP in terms of relative frequencies for treatment type in intensive care units worldwide. Time: 10 days after EBPT initiationDescription: For each EBP treatment will be described absolute and relative frequency of chosen anticoagulation strategy
Measure: To describe EBP in terms of technical characteristics in intensive care units worldwide. Time: 10 days after EBPT initiationDescription: For each EBP treatment will be described average flow rates (variables: blood flow rate, dialysate flow rate, replacement flow rate pre-filter, replacement flow rate post-filter, effluent flow rate, net ultrafiltration rate).
Measure: To describe EBP in terms of average flow rates in intensive care units worldwide. Time: 10 days after EBPT initiationThis is a prospective observational parallel group cohort study that will aim to recruit 220 participants who were admitted to the hospital with COVID-19 between 1st March 2020 and 30th June 2020 (Group A - 110 participants who had COVID-19 with AKI; Group B - 110 participants who had COVID-19 without AKI). Data from groups A and B will be compared with AKI and non-AKI groups from an existing study database (ARID study, n=1125) who were recruited before the outbreak of the COVID-19 pandemic (recruitment 2013-2016) and who have all completed at least three years of follow up. Participants who have recovered from COVID-19 will be matched for analysis to participants from the ARID study for AKI status, baseline estimated glomerular filtration rate (eGFR) stage, age (± 5 years) and presence of diabetes. Potential participants will receive a letter of invitation along with a comprehensive participant information sheet (PIS).
Description: Kidney disease progression will be defined as a decline in estimated glomerular filtration rate (eGFR; ml/min/1.73m2) of ≥30%
Measure: Incidence of kidney disease progression at 12 months. Time: 12 months after hospital discharge.Description: Albuminuria will be defined as a urine albumin to creatinine ratio (UACR) of >30mg/mmol.
Measure: Incidence of albuminuria at 6-9 months. Time: 6-9 months after hospital discharge.Description: Albuminuria will be defined as a urine albumin to creatinine ratio (UACR) of >30mg/mmol.
Measure: Incidence of albuminuria at 12-15 months. Time: 12-15 months after hospital discharge.Description: Combined kidney disease progression outcome of ≥30% decline in eGFR (ml/min.1.73m2) and/or albuminuria (UACR>30mg/mmol).
Measure: Incidence of combined kidney disease progression and albuminuria at 6-9 months. Time: 6-9 months after hospital discharge.Description: Combined kidney disease progression outcome of ≥30% decline in eGFR (ml/min.1.73m2) and/or albuminuria (UACR>30mg/mmol).
Measure: Incidence of combined kidney disease progression and albuminuria at 12-15 months. Time: 12-15 months after hospital discharge.Description: Multi-variable Cox proportional hazards models will be used to assess the factors associated with all-cause mortality
Measure: Factors associated with all-cause mortality at 6-9 months. Time: 6-9 months after hospital discharge.Description: Multi-variable Cox proportional hazards models will be used to assess the factors associated with all-cause mortality
Measure: Factors associated with all-cause mortality at 12-15 months. Time: 12-15 months after hospital discharge.Description: Number of hospital readmissions
Measure: Incidence of hospital readmissions at 6-9 months Time: 6-9 months after hospital discharge.Description: Number of hospital readmissions
Measure: Incidence of hospital readmissions at 12-15 months Time: 12-15 months after hospital discharge.This is a prospective observational cohort study that will aim to recruit 60 participants who have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI during their hospital stay. Potential participants will be approached either by telephone by a member of the research team or via clinics (nephrology, post-ICU follow up clinics).
Description: Global organ structure will be assessed through structural T1- and T2-weighted MRI scans which will provide information about automated segmentation and volume assessment of whole kidney (and both cortex and medulla) as well as other abdominal organs (including liver and spleen). Global organ structure will also be assessed through longitudinal (T1) and transverse (T2) relaxation time mapping. T1 and T2 increase with tissue inflammation, oedema and fibrosis. A respiratory-triggered inversion recovery (IR) spin-echo echo-planar scheme will be used for abdominal T1 mapping and a Gradient and spin echo (T2-GraSE) scheme for abdominal T2 mapping.
Measure: MRI assessment of global organ structure at 12 months. Time: 12 monthsDescription: R2* data will be acquired using a multi-echo fast field echo (mFFE) scheme to assess thrombi. Conventionally R2* mapping is used as a measure of oxygenation, but R2*is likely to be altered by other factors in COVID-19, including oedema and small vessel thrombotic processes.
Measure: MRI assessment of thrombi (R2*) at 12 months. Time: 12 monthsDescription: Mean transit time and perfusion depicting changes in microvascular blood flow and large vessel flow/thrombosis will be determined using a FAIR labelling scheme with a multi-slice spin-echo echo-planar imaging readout and multiple labelling delay times.
Measure: MRI assessment of organ perfusion (Arterial spin labelling [ASL]) at 12 months. Time: 12 monthsDescription: Global organ structure will be assessed through structural T1- and T2-weighted MRI scans which will provide information about automated segmentation and volume assessment of whole kidney (and both cortex and medulla) as well as other abdominal organs (including liver and spleen). Global organ structure will also be assessed through longitudinal (T1) and transverse (T2) relaxation time mapping. T1 and T2 increase with tissue inflammation, oedema and fibrosis. A respiratory-triggered inversion recovery (IR) spin-echo echo-planar scheme will be used for abdominal T1 mapping and a Gradient and spin echo (T2-GraSE) scheme for abdominal T2 mapping.
Measure: MRI assessment of global organ structure. Time: 3-6 and 24 monthsDescription: R2* data will be acquired using a multi-echo fast field echo (mFFE) scheme to assess thrombi. Conventionally R2* mapping is used as a measure of oxygenation, but R2*is likely to be altered by other factors in COVID-19, including oedema and small vessel thrombotic processes.
Measure: MRI assessment of thrombi (R2*). Time: 3-6 and 24 monthsDescription: Mean transit time and perfusion depicting changes in microvascular blood flow and large vessel flow/thrombosis will be determined using a FAIR labelling scheme with a multi-slice spin-echo echo-planar imaging readout and multiple labelling delay times.
Measure: MRI assessment of organ perfusion (ASL) Time: 3-6 and 24 monthsDescription: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with estimated glomerular filtration rate (ml/min/1.73m2).
Measure: Correlations between MRI measures with estimated glomerular filtration rate. Time: 3-6, 12 and 24 monthsDescription: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with urine albumin creatinine ratio (mg/mmol) and urine protein creatinine ratio (mg/mmol).
Measure: Correlations between MRI measures with urine albumin and protein creatinine ratios. Time: 3-6, 12 and 24 monthsDescription: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the mental component score. A score between 0 and 100 is calculated from the 36-Item Short-Form Health Survey; the higher the score, the better the quality of life mental domain.
Measure: Correlations between MRI measures with mental component score. Time: 3-6, 12 and 24 monthsDescription: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the physical component score. A score between 0 and 100 is calculated from the 36-Item Short-Form Health Survey; the higher the score, the better the quality of life physical domain.
Measure: Correlations between MRI measures with physical component score. Time: 3-6, 12 and 24 monthsDescription: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the health state score calculated from the European Quality of Life 5-Dimensions questionnaire. The health state score ranges from -0.285 (for the worst health state) to 1 (for the best health state).
Measure: Correlations between MRI measures with health state score. Time: 3-6, 12 and 24 monthsDescription: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the visual analogue score from the European Quality of Life 5-Dimensions questionnaire. The visual analogue score uses a thermometer-like scale numbered from 0 to 100; the higher the score, the better the health state.
Measure: Correlations between MRI measures with visual analogue score. Time: 3-6, 12 and 24 monthsDescription: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the fatigue score from the Fatigue Severity Scale, a 9-item questionnaire scored on a 7-point scale (minimum score=9; maximum score=63); the higher the score, the greater the fatigue severity.
Measure: Correlations between MRI measures with fatigue severity. Time: 3-6, 12 and 24 monthsDescription: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the fatigue score from the Visual Analogue Fatigue Scale, which uses an horizontal line scale numbered from 0 to 10; the higher the score, the higher the fatigue.
Measure: Correlations between MRI measures with fatigue score. Time: 3-6, 12 and 24 monthsDescription: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with skin autofluorescence levels (arbitrary units) measured with the validated Autofluorescence Reader Standard Unit (SU) version 2.4.3 (AGE Reader SU, DiagnOptics Technologies BV, Aarhusweg 4-9, Groningen, The Netherlands).
Measure: Correlations with MRI measures with skin autofluorescence levels. Time: 3-6, 12 and 24 monthsDescription: Mean change in mental component score. A score between 0 and 100 is calculated from the 36-Item Short-Form Health Survey; the higher the score, the better the quality of life mental domain.
Measure: Mean change in mental component score. Time: 3-6, 12 and 24 monthsDescription: Mean change in physical component score. A score between 0 and 100 is calculated from the 36-Item Short-Form Health Survey; the higher the score, the better the quality of life physical domain.
Measure: Mean change in physical component score. Time: 3-6, 12 and 24 monthsDescription: Mean change in health state score calculated from the European Quality of Life 5-Dimensions questionnaire. The health state score ranges from -0.285 (for the worst health state) to 1 (for the best health state).
Measure: Mean change in health state score. Time: 3-6, 12 and 24 monthsDescription: Mean change in visual analogue score from the European Quality of Life 5-Dimensions questionnaire. The visual analogue score uses a thermometer-like scale numbered from 0 to 100; the higher the score, the better the health state.
Measure: Mean change in visual analogue score. Time: 3-6, 12 and 24 monthsDescription: Mean change in fatigue score as assessed by the Fatigue Severity Scale, a 9-item questionnaire scored on a 7-point scale (minimum score=9; maximum score=63); the higher the score, the greater the fatigue severity.
Measure: Mean change in fatigue severity scale. Time: 3-6, 12 and 24 monthsDescription: Mean change in fatigue score as assessed by the Visual Analogue Fatigue Scale, which uses an horizontal line scale numbered from 0 to 10; the higher the score, the higher the fatigue.
Measure: Mean change in fatigue score. Time: 3-6, 12 and 24 monthsDescription: Mean change in skin autofluorescence levels (arbitrary units) measured with the AGE Reader.
Measure: Mean change in skin autofluorescence levels. Time: 3-6, 12 and 24 monthsDescription: Assessment of kidney disease progression defined as decrease in estimated glomerular filtration rate (eGFR) of ≥25% associated with a decline in eGFR stage.
Measure: Incidence of kidney disease progression. Time: 3-6, 12 and 24 monthsDescription: Recording of the number of participants who developed any cardiovascular events.
Measure: Incidence of cardiovascular events. Time: 3-6, 12 and 24 monthsDescription: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with all-cause mortality using multi-variable Cox proportional hazards models.
Measure: Correlations between MRI measures with all-cause mortality. Time: 12 and 24 monthsRecent different biomarkers of acute kidney injury (AKI) have been manufactured by pharmaceutical industry. Studies proved that Neutrophil gelatinase-associated lipocalin (NGAL) and cystatin c are effective predictive biomarkers for early acute kidney injury in septic patients and in children after cardiopulmonary bypass. This study hypothesize that both cystatin c and Neutrophil gelatinase-associated lipocalin can predict AKI in patients with COVID-19 before elevation of serum urea and creatinine which may help early interference.
Description: biochmical tests for detection of NGAL and Cystatin c in Covid 19 patients
Measure: measure both cystatin c and Neutrophil gelatinase-associated lipocalin every other day for 3 times (NGAL) as recent biomarkers in prediction of AKI in patients with COVID-19. Time: one week starting from hospital admissionDescription: increased serum creatinine or urea
Measure: development of acute kidney injury lipocalin (NGAL) to AKI severity and prognosis of AKI in patients with COVID-19 infection Time: one week starting from day of admissionMultiple lines of evidence support a central role of iron in causing acute kidney injury (AKI), including the finding that prophylactic administration of iron chelators attenuates AKI in animal models. Patients undergoing cardiac surgery may be particularly susceptible to iron-mediated kidney injury due to the profound hemolysis that often occurs from cardiopulmonary bypass. The investigators will test in a phase 2, randomized, double-blind, placebo-controlled trial whether prophylactic administration of deferoxamine decreases the incidence of AKI following cardiac surgery.
Description: Urine output <0.5 ml/kg/h for ≥6 consecutive hours, an increase in serum creatinine ≥0.3 mg/dl within the first 48h, an increase in serum creatinine ≥50% in 7 days, or receipt of renal replacement therapy in 7 days.
Measure: Acute Kidney Injury Time: 7 daysDescription: Urine levels of NGAL and KIM-1
Measure: Renal tubular injury Time: 3 daysDescription: Peak postoperative troponin I elevation >10 times the 99th percentile upper reference limit
Measure: Postoperative myocardial injury Time: 2 daysDescription: New onset postoperative atrial fibrillation (patients with atrial fibrillation at baseline will be excluded)
Measure: Atrial fibrillation Time: 7 daysDescription: Requirement for mechanical ventilation >24h postoperatively
Measure: Prolonged mechanical ventilation Time: 24 hoursDescription: Life-threatening organ dysfunction caused by a dysregulated host response to infection. Organ dysfunction is defined as an acute increase in the total SOFA score ≥2 points consequent to the infection.
Measure: Sepsis Time: 7 daysDescription: 28 minus the number of days ventilated. Patients who die within 28 days will be assigned 0 ventilator-free days.
Measure: Ventilator-free days Time: 28 daysDescription: 28 minus the number of days hospitalized. Patients who die within 28 days will be assigned 0 hospital-free days.
Measure: Hospital-free days Time: 28 daysDescription: 28 minus the number of days in the ICU. Patients who die within 28 days will be assigned 0 ICU-free days.
Measure: ICU-free days Time: 28 daysThis Randomized Control Trial (RCT) proposes combination of extracorporeal cytokine removal by plasma exchange (PLEX) and additional infusion of convalescent plasma (CCP) collected from COVID-19 recovered individuals at the end of the PLEX procedure. The combination of cytokine removal by PLEX and CCP infusion is in onvestigators opinion more rational compared to CCP infusion alone and as such probably more effective in reducing the duration of mechanical ventilation, length of stay in the intensive care unit, and potentially also mortality.
Description: The primary outcome is days alive and out of hospital from randomisation to day 90.
Measure: Alive at Day 90th Time: 90 daysDescription: Serious adverse events - new episode of septic shock, anaphylactic reaction to CCP, invasive fungal infection, TACO, TRALI.
Measure: Day 8 serious adverse events Time: 8 daysDescription: All-cause mortality at day 28
Measure: Day 28 all cause mortality Time: 28 daysDescription: Days alive without life support at day 90
Measure: Days alive without life support at day 90 Time: 90 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports