|drug46||3D Telemedicine Wiki||0.25|
|drug82||ADAM Sensor Wiki||0.22|
|drug194||African American Sender in Informational Videos. Wiki||0.22|
|drug103||ARCT-021 Dose Regimen 1 Wiki||0.22|
|drug3720||White Sender in Informational Videos Wiki||0.22|
|drug57||68Ga-DX600 PET/CT Wiki||0.22|
|drug78||ACT-541478 30 mg Wiki||0.22|
|drug280||Any drug used to treat Covid-19 Wiki||0.22|
|drug2563||Placebo videos Wiki||0.22|
|drug62||AAZ Covid-19 rapid test Wiki||0.22|
|drug106||ARFC mask Wiki||0.22|
|drug50||5-ALA-Phosphate + SFC (5-ALA + SFC) Wiki||0.22|
|drug60||A short video intervention Wiki||0.22|
|drug100||ARCT-021 Dose 2 Wiki||0.22|
|drug41||35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients) Wiki||0.22|
|drug42||35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients ) Wiki||0.22|
|drug81||ACT-541478 high or low dose (or placebo) Wiki||0.22|
|drug90||AMA Acknowledgement Drug Pricing Wiki||0.22|
|drug2579||Plasma expansion with Ringer's Acetate Wiki||0.22|
|drug2395||PHQ-9 Depression Scale Wiki||0.22|
|drug69||ACE inhibitor, angiotensin receptor blocker Wiki||0.22|
|drug96||ARBIDOL 100 MG KAPSUL Wiki||0.22|
|drug75||ACT-541478 10 mg Wiki||0.22|
|drug2230||Non interventional study Wiki||0.22|
|drug2827||Recombinant human alkaline phosphatase Wiki||0.22|
|drug3769||acute kidney injury Wiki||0.22|
|drug76||ACT-541478 100 mg Wiki||0.22|
|drug3719||White Sender in Acknowledgement Wiki||0.22|
|drug102||ARCT-021 Dose 4 Wiki||0.22|
|drug1361||GAD-7 General anxiety disorder scale Wiki||0.22|
|drug1799||LSALT peptide Wiki||0.22|
|drug3162||Sodium bicarbonate Wiki||0.22|
|drug506||Blood Transfusion Wiki||0.22|
|drug104||ARCT-021 Dose Regimen 2 Wiki||0.22|
|drug2795||Racial Inequality Highlighted Wiki||0.22|
|drug2213||No Racial Inequality Highlighting Wiki||0.22|
|drug77||ACT-541478 1000 mg Wiki||0.22|
|drug101||ARCT-021 Dose 3 Wiki||0.22|
|drug40||300 mg of omega3-FA Wiki||0.22|
|drug193||African American Sender Acknowledgement Wiki||0.22|
|drug79||ACT-541478 300 mg Wiki||0.22|
|drug80||ACT-541478 dose E1 Wiki||0.22|
|drug99||ARCT-021 Dose 1 Wiki||0.22|
|drug44||38-questions questionnaire Wiki||0.22|
|drug119||ATAFENOVIR 200 MG KAPSUL Wiki||0.22|
|drug61||A vignette intervention Wiki||0.22|
|drug164||Acknowledgement Racial Injustice AMA Wiki||0.22|
|drug246||Angiotensin II Wiki||0.15|
|drug916||Conventional treatment Wiki||0.15|
|drug4157||unfractionated Heparin Wiki||0.15|
|drug38||2D Telemedicine Wiki||0.15|
|drug1978||Matching placebo Wiki||0.13|
|drug3221||Standard of Care Wiki||0.07|
|D014947||Wounds and Injuries NIH||0.32|
|D007049||Iatrogenic Disease NIH||0.22|
|D012772||Shock, Septic NIH||0.15|
|D018746||Systemic Inflammatory Response Syndrome NIH||0.13|
|D009102||Multiple Organ Failure NIH||0.10|
|D009203||Myocardial Ischemia NIH||0.05|
|D012128||Respiratory Distress Syndrome, Adult NIH||0.03|
|D018352||Coronavirus Infections NIH||0.03|
|D045169||Severe Acute Respiratory Syndrome NIH||0.03|
|D016638||Critical Illness NIH||0.03|
|D012127||Respiratory Distress Syndrome, Newborn NIH||0.02|
|D055371||Acute Lung Injury NIH||0.02|
There are 21 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 measurementMeasure: 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 intervention
Description: 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 point
Description: 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 point
The 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 randomization
Description: 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 randomization
Description: 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 randomization
Description: 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 randomization
Description: MI, coronary revascularization, acute renal failure, or postoperative ischemic stroke.Measure: A composite endpoint of all-cause mortality, Time: 30 days after randomization
Description: Length of hospital stayMeasure: Length of hospital stay. Time: At hospital discharge, up to 1 year
Description: All cause postoperative mortality, Postoperative MI, Postoperative coronary revascularization, Postoperative stroke,Postoperative acute renal failureMeasure: The investigators will examine individual rates of the outcomes that consist of individual components of the primary endpoint. Time: 90 days after randomization
The 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) termsMeasure: Renal failure Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) termsMeasure: Heart failure Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) termsMeasure: EKG disturbance Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) termsMeasure: Hepatic failure Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) termsMeasure: Anemia Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) termsMeasure: Leucopenia Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) termsMeasure: Vascular disease Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) termsMeasure: Toxidermia Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) termsMeasure: Osteoarticular adverse event Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) termsMeasure: Death Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) termsMeasure: Acute respiratory distress syndrome Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Description: defined by the Medical Dictionary for Regulatory Activities (MeDRA) termsMeasure: Pulmonary embolism or pulmonary hypertension Time: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
The 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 InjuryMeasure: Rate of Acute Kidney Injury Time: From date of admission until the date of discharge or death from any cause, up to 60 days
Description: death from any cause in the hospitalMeasure: Rate of Death Time: From date of admission until the date of death from any cause, up to 60 days
Description: days from admission to discharge or deathMeasure: the length of hospital stay Time: From date of admission until the date of discharge or death from any cause, up to 60 days
The 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 scoreMeasure: Acute Kidney Injury Time: During Intensive Care, an estimated average of 10 days.
Description: Acute Respiratory Distress Syndrome yes/noMeasure: ARDS Time: During intensive care, an estimated average of 10 days.
Description: Death within 30 days of ICU admissionMeasure: 30 day mortality Time: 30 days
Description: Death within 1 year of ICU admissionMeasure: 1 year mortality Time: 1 year
Description: Development of Chronic Kidney DiseaseMeasure: Chronic Kidney Disease Time: 60 days and 1 year after ICU admission
Description: Sequential Organ Failure Score as a continuous variableMeasure: 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) criteriaMeasure: Incidence of AKI Time: Within 7 days after admission
Description: Serial biomarker assessmentMeasure: Renal function changes during hospital stay Time: from hospital admission til discharge up to 3 months
Description: As determined by KDIGO criteriaMeasure: Incidence of chronic kidney disease Time: 3 months post-hospital admission
In 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 measurementMeasure: Sensibility and specificity of urinary Time: Occurence of AKI 7 days after urinary biomarkers measurement
Description: Sensibility and specificity of urinary [TIMP-2]*[IGFBP-7] > 0,3 to predict AKI worsening, renal replacement therapy requirement or persistant AKIMeasure: Sensibility and specificity of urinary Time: Occurnce of AKI worsening, renal replacement therapy requirement or persistant AKI, 7 days after urinary biomarkers mesurement
To 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 days
Description: 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 days
Description: Oxygen therapy provided as non-invasive therapy for ARDS patients.Measure: Time on nasal cannula or oxygen masks Time: 28 days
Description: 28 day mortality - all cause and attributableMeasure: 28 day mortality - all cause and attributable Time: 28 days
Description: ICU and hospitalization length of stay (days)Measure: ICU and hospitalization length of stay (days) Time: 28 days
Description: Swab (nasopharyngeal, nasal, throat, sputum, or lower respiratory tract) at baseline (Day 1) and every 3 days thereafter until eradication → virologic clearance rateMeasure: SARS-CoV2 testing Time: 28 days
Description: 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 days
Description: Vasopressor free daysMeasure: Vasopressor free days Time: 28 days
Description: 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 days
Description: Change in daily mMRC dyspnea and SOFA scores (0 to 4) with 4 being the most severe outcomeMeasure: Change in modified Medical Research Council (mMRC) dyspnea and Sequential Organ Failure Assessment (SOFA) scores Time: 28 days
Description: Incidence of other organ (non-lung) disordersMeasure: Incidence of non-lung disorders Time: 28 days
Description: Change in liver function tests (ALT, AST, and total bilirubin levels) from baselineMeasure: Measures of liver dysfunction Time: 28 days
Description: Change in SCr and eGFR from baselineMeasure: Measures of kidney dysfunction Time: 28 days
Description: Change in highly-sensitive troponin (hs-troponin) from baselineMeasure: Measures of cardiac dysfunction Time: 28 days
Description: Change from baseline ACT, aPTT, and/or PT/INR levelsMeasure: Measures of coagulopathies Time: 28 days
Description: Change in baseline antiviral immunoglobulins (IgG, IgM) at EOS.Measure: Changes in immunogenic responses Time: 28 days
Description: Changes in total healthcare costs from admission to discharge between treatment groups.Measure: Healthcare outcomes Time: 28 days
Description: 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 levelsMeasure: Molecular changes in pro-inflammatory pathways Time: 28 days
Description: Pharmacokinetics of LSALT peptide over the study period.Measure: Pharmacokinetics of LSALT peptide Time: 28 days
The 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 AKIMeasure: Occurence of acute kidney injury (AKI) Time: within 7 days after beginning of moderate or severe ARDS
Description: e.g., Analysis of interleukin (IL) 6, IL8Measure: Add-on analysis: pro- and antiinflammatory mediators Time: within 7 days after beginning of moderate or severe ARDS
Severe 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-19Measure: Incidence of Acute kidney injury in COVID-19 Time: 7 days
Description: This is the number of deaths in COVID-19 AKI patientsMeasure: All-cause mortality in AKI patients Time: 7 days
This 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 OutcomeMeasure: Any stage of acute kidney injury Time: 7 days
Description: Renal replacement therapy requirement at the clinicians' discretionMeasure: need for RRT in first 7 days Time: 7 days
Description: ICU mortalityMeasure: Mortality Time: 7 and 28 days
Description: DurationMeasure: Duration of mechanical ventilation Time: 7 and 28 days
Description: DurationMeasure: Duration of vasopressor support Time: 7 and 28 days
Clinical 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. 1400 patients will be included in the study that is conducted in approx. 100 ICU's in Europe and North America 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 mortalityMeasure: 28-day all-cause mortality Time: 28 days
Description: 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 Days
Description: 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 days
Description: 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 days
Description: Time to death through Day 90.Measure: To investigate the effect of recAP on 90-day allcause mortality Time: 90 days
The 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) criteriaMeasure: Incidence of any stage of acute kidney injury Time: 14 days
Description: MortalityMeasure: Mortality Time: 14-day, hospital, and intensive care unit (ICU) mortality
Description: Defined by return of creatinine to < 1.5 times of baselineMeasure: Renal recovery Time: 14 days
Description: PercentageMeasure: Percentage of patients who receive renal replacement therapy Time: 14 days
Description: Percentage of participants who are dialysis dependentMeasure: Percentage of participants who are dialysis dependent Time: Through study completion, an average of 90 days
Description: Days without vasoactive medications and mechanical ventilationMeasure: Free-days of vasoactive medications and mechanical ventilation Time: Day 30
Description: Length of intensive care unit and hospital stayMeasure: Length of intensive care unit and hospital stay Time: Through study completion, an average of 90 days
Description: Congestive heart failure, Arrhythmia, Acute respiratory distress syndrome, Septic shock, Acute cardiac injury, pneumoniaMeasure: Number of participants with consequences following AKI Time: Through study completion, an average of 90 days
Description: Time from illness onset to need for mechanical ventilator supportMeasure: Time from illness onset to need for mechanical ventilator support Time: Through study completion, an average of 30 days
The 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 72hMeasure: Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection Time: 7 months
This 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 outputMeasure: Acute Kidney Injury (AKI) Time: 14 days
Description: Survival to ICU discharge or Day 14Measure: Survival Time: 14 days
Description: The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapyMeasure: Rate of Extracorporeal Therapy Requirement Time: 14 days
Description: >20% fluid overload as defined as the net fluid balance since ICU admission (in liters) divided by ICU admission weightMeasure: Fluid overload Time: Day of Enrollment
Description: The exposure of enrolled patients to known nephrotoxic medications, including diureticsMeasure: Rate of nephrotoxic medication exposure Time: Day of Enrollment
Since 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 dialysis
Description: Number of hours until a dialyzer clots in the first 72 hours of dialysisMeasure: Time-free of clotting Time: Day 3 of dialysis
Description: The amount of dialyzers used in the first 72 hours of hemodialysisMeasure: Number of dialyzers used Time: Day 3 of dialysis
Description: Variation in dialysis system and vascular access pressures in the first 72 h of dialysisMeasure: Pressure variation Time: Day 3 of dialysis
Description: Variation in urea sieving between the first, second and third days of dialysisMeasure: Urea sieving Time: Day 3 of dialysis
Description: Time of dialysis stop due to clotting in the first 72 hoursMeasure: Downtime of dialysis Time: Day 3 of dialysis
This 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 days
Our 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 days
Description: 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-treatment
Description: 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 days
Description: Ventilator-free days to 28 daysMeasure: Vent-Free Time: 28 days
Description: Hospital-free days to 60 daysMeasure: Hospital-Free Time: 60 days post-index hospitalization
Septic 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 catecholaminesMeasure: Time to discontinuation of catecholamines Time: Until shock resolution, up to 14 days
Description: 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 enrollment
Description: Assessment of all-cause mortality within hospital admissionMeasure: In-hospital mortality Time: Up to 3 months following enrollment
Description: Days free of renal replacement therapy from enrollment up to day 28Measure: Renal replacement therapy-free days Time: Within 28 days of enrollment
Description: Incidence of venous thromboembolism, arrhythmia, extremity hypoperfusion, delirium, new ischemic event, new infectionMeasure: Safety outcomes Time: Up to 72 hours following shock resolution, no longer than 17 days from enrollment
Data processed on September 26, 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