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  • HP:0001919: Acute kidney injury
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    HP:0001919: Acute kidney injury

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (89)


    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

    Correlated MeSH Terms (17)


    Name (Synonyms) Correlation
    D058186 Acute Kidney Injury NIH 1.00
    D014947 Wounds and Injuries NIH 0.34
    D018746 Systemic Inflammatory Response Syndrome NIH 0.19
    Name (Synonyms) Correlation
    D057049 Thrombotic Microangiopathies NIH 0.19
    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

    Correlated HPO Terms (2)


    Name (Synonyms) Correlation
    HP:0100806 Sepsis HPO 0.12
    HP:0001658 Myocardial infarction HPO 0.04

    Clinical Trials

    Navigate: Correlations   HPO

    There are 29 clinical trials


    1 MR-Evaluation of Renal Function In Septic Patients

    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.

    NCT02765191
    Conditions
    1. Sepsis, Severe
    2. Acute Kidney Injury
    3. COVID-19
    Interventions
    1. Other: Plasma expansion with Ringer's Acetate
    MeSH:Sepsis Acute Kidney Injury
    HPO:Acute kidney injury Sepsis

    Primary Outcomes

    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 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
    2 CSP #599 - Transfusion Trigger After Operations in High Cardiac Risk Patients (TOP)

    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).

    NCT03229941
    Conditions
    1. Myocardial Infarction
    2. Coronary Revascularization
    3. Acute Renal Failure
    Interventions
    1. Procedure: Blood Transfusion
    MeSH:Acute Kidney Injury Myocardial Infarction Infarction
    HPO:Acute kidney injury Myocardial infarction

    Primary Outcomes

    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

    Secondary Outcomes

    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 stay

    Measure: Length of hospital stay.

    Time: At hospital discharge, up to 1 year

    Other Outcomes

    Description: 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 randomization
    3 Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

    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).

    NCT04314817
    Conditions
    1. Coronavirus
    2. Iatrogenic Disease
    3. Acute Kidney Injury
    4. ARDS, Human
    Interventions
    1. Drug: Any drug used to treat Covid-19
    MeSH:Coronavirus Infections Respiratory Distress Syndrome, Adult Acute Kidney Injury Iatrogenic Disease
    HPO:Acute kidney injury

    Primary Outcomes

    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 17/03/2020

    Secondary Outcomes

    Description: 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 17/03/2020

    Description: 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 17/03/2020

    Description: 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 17/03/2020

    Description: 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 17/03/2020

    Description: 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 17/03/2020

    Description: 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 17/03/2020

    Description: 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 17/03/2020

    Description: 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 17/03/2020

    Description: 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 17/03/2020

    Description: 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 17/03/2020

    Description: 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 17/03/2020
    4 Acute Kidney Injury in Patients Hospitalized With COVID-19 in Wuhan, China: a Single-center Retrospective Observational Study

    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.

    NCT04316299
    Conditions
    1. COVID-19
    2. Acute Kidney Injury
    3. Kidney Function
    MeSH:Acute Kidney Injury Wounds and Injuries
    HPO:Acute kidney injury

    Primary Outcomes

    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 days

    Secondary Outcomes

    Description: 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 days

    Description: 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 days
    5 Uppsala Intensive Care Study of Mechanisms for Organ Dysfunction in Covid-19

    The study aims to investigate organ dysfunction and biomarkers in patients with suspected or verified COVID-19 during intensive care at Uppsala University Hospital.

    NCT04316884
    Conditions
    1. COVID-19
    2. Organ Dysfunction Syndrome Sepsis
    3. Organ Dysfunction Syndrome, Multiple
    4. Septic Shock
    5. Acute Kidney Injury
    6. Acute Respiratory Distress Syndrome
    MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Acute Kidney Injury Syndrome Systemic Inflammatory Response Syndrome Multiple Organ Failure
    HPO:Acute kidney injury

    Primary Outcomes

    Description: KDIGO AKI score

    Measure: Acute Kidney Injury

    Time: During Intensive Care, an estimated average of 10 days.

    Secondary Outcomes

    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 days

    Description: Death within 1 year of ICU admission

    Measure: 1 year mortality

    Time: 1 year

    Description: Development of Chronic Kidney Disease

    Measure: Chronic Kidney Disease

    Time: 60 days and 1 year after ICU admission

    Description: Sequential Organ Failure Score as a continuous variable

    Measure: SOFA-score

    Time: During Intensive Care, an estimated average of 10 days.
    6 Renal Outcome in Patients With Coronavirus Disease 2019 (COVID-19)

    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.

    NCT04353583
    Conditions
    1. Acute Kidney Injury
    2. Corona Virus Infection
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Acute Kidney Injury
    HPO:Acute kidney injury

    Primary Outcomes

    Description: As determined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria

    Measure: Incidence of AKI

    Time: Within 7 days after admission

    Secondary Outcomes

    Description: Serial biomarker assessment

    Measure: Renal function changes during hospital stay

    Time: from hospital admission til discharge up to 3 months

    Description: As determined by KDIGO criteria

    Measure: Incidence of chronic kidney disease

    Time: 3 months post-hospital admission
    7 The Role of Noncoding RNAs in COVID-19 and COVID-19 Associated Acute Kidney Injury (MiRCOVID)

    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.

    NCT04381351
    Conditions
    1. COVID-19
    MeSH:Acute Kidney Injury
    HPO:Acute kidney injury

    Primary Outcomes

    Measure: predicitive value of noncoding RNAs in COVID-19 associated organ dysfunction

    Time: 12 months
    8 Urinary Biomarkers (TIMP-2 and IGFBP7) for Early Diagnostic Assessment of Acute Kidney Injury in Patients With SARS-CoV-2 (COVID-19)

    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.

    NCT04393428
    Conditions
    1. COVID-19
    2. Renal Replacement Therapy
    3. Acute Kidney Injury
    Interventions
    1. Other: [TIMP-2]*[IGFBP-7]
    MeSH:Acute Kidney Injury
    HPO:Acute kidney injury

    Primary Outcomes

    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 measurement

    Secondary Outcomes

    Description: 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 mesurement
    9 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)

    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.

    NCT04402957
    Conditions
    1. COVID
    2. Severe Acute Respiratory Syndrome
    3. Sars-CoV2
    4. Acute Kidney Injury
    Interventions
    1. Drug: LSALT peptide
    2. Drug: Placebo
    MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Acute Kidney Injury Syndrome Wounds and Injuries
    HPO:Acute kidney injury

    Primary Outcomes

    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

    Secondary Outcomes

    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 attributable

    Measure: 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 rate

    Measure: 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 days

    Measure: 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 outcome

    Measure: 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) disorders

    Measure: Incidence of non-lung disorders

    Time: 28 days

    Description: Change in liver function tests (ALT, AST, and total bilirubin levels) from baseline

    Measure: Measures of liver dysfunction

    Time: 28 days

    Description: Change in SCr and eGFR from baseline

    Measure: Measures of kidney dysfunction

    Time: 28 days

    Description: Change in highly-sensitive troponin (hs-troponin) from baseline

    Measure: Measures of cardiac dysfunction

    Time: 28 days

    Description: Change from baseline ACT, aPTT, and/or PT/INR levels

    Measure: 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 levels

    Measure: 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
    10 Prediction of Acute Kidney Injury in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

    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.

    NCT04406688
    Conditions
    1. Acute Kidney Injury
    2. COVID-19
    3. ARDS
    MeSH:Acute Kidney Injury Wounds and Injuries
    HPO:Acute kidney injury

    Primary Outcomes

    Description: Occurence of moderate or severe AKI

    Measure: Occurence of acute kidney injury (AKI)

    Time: within 7 days after beginning of moderate or severe ARDS

    Secondary Outcomes

    Measure: Occurence of transient and persistent AKI

    Time: within 7 days after beginning of moderate or severe ARDS

    Measure: Occurence of Renal replacement therapy during hospital stay

    Time: up to 4 weeks after beginning of moderate or severe ARDS

    Measure: Duration of renal replacement therapy

    Time: up to 4 weeks after beginning of moderate or severe ARDS

    Measure: Mortality

    Time: up to 4 weeks after beginning of moderate or severe ARDS

    Measure: Duration of mechanical ventilation

    Time: up to 4 weeks after beginning of moderate or severe ARDS

    Measure: Duration of vasopressor administration

    Time: up to 4 weeks after beginning of moderate or severe ARDS

    Measure: ICU length of stay

    Time: up to 4 weeks after beginning of moderate or severe ARDS

    Measure: Hospital length of stay

    Time: up to 4 weeks after beginning of moderate or severe ARDS

    Other Outcomes

    Description: 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 ARDS
    11 Acute Kidney Injury In Corona Virus Infection Disease (COVID19) in United Kingdom

    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.

    NCT04407156
    Conditions
    1. COVID
    2. AKI
    Interventions
    1. Other: acute kidney injury
    MeSH:Acute Kidney Injury
    HPO:Acute kidney injury

    Primary Outcomes

    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 days

    Secondary Outcomes

    Description: This is the number of deaths in COVID-19 AKI patients

    Measure: All-cause mortality in AKI patients

    Time: 7 days
    12 AKI Biomarkers for Prediction of Acute Kidney Injury in Critically Ill Patients With COVID-19 and Respiratory Disease

    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.

    NCT04408248
    Conditions
    1. COVID
    2. Acute Respiratory Failure
    3. Acute Kidney Injury
    MeSH:Respiratory Insufficiency Acute Kidney Injury
    HPO:Acute kidney injury

    Primary Outcomes

    Description: As defined by Kidney Diseases: Improving Global Outcome

    Measure: Any stage of acute kidney injury

    Time: 7 days

    Secondary Outcomes

    Description: Renal replacement therapy requirement at the clinicians' discretion

    Measure: need for RRT in first 7 days

    Time: 7 days

    Description: ICU mortality

    Measure: Mortality

    Time: 7 and 28 days

    Description: Duration

    Measure: Duration of mechanical ventilation

    Time: 7 and 28 days

    Description: Duration

    Measure: Duration of vasopressor support

    Time: 7 and 28 days
    13 A DB, Placebo-Controlled, Two-Arm Parallel-Group, Phase 3 RCT to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients With SA-AKI

    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. 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.

    NCT04411472
    Conditions
    1. Acute Kidney Injury Due to Sepsis
    Interventions
    1. Biological: Recombinant human alkaline phosphatase
    2. Other: Placebo
    MeSH:Sepsis Acute Kidney Injury
    HPO:Acute kidney injury Sepsis

    Primary Outcomes

    Description: To demonstrate an effect of recAP on 28 day all cause mortality

    Measure: 28-day all-cause mortality

    Time: 28 days

    Secondary Outcomes

    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
    14 A Multi-center, Randomized, Case Controlled, Double-blind, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 Therapy) in COVID-19 Subjects With Acute Kidney Injury Receiving Renal Replacement Therapy

    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.

    NCT04445220
    Conditions
    1. COVID-19
    2. Acute Kidney Injury
    Interventions
    1. Biological: SBI-101
    MeSH:Acute Kidney Injury Wounds and Injuries
    HPO:Acute kidney injury

    Primary Outcomes

    Measure: Safety and tolerability as measured by incidence of IP-related serious adverse events

    Time: Outcomes and Serious Adverse Events through Day 180
    15 Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury

    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.

    NCT04445259
    Conditions
    1. COVID
    2. Acute Kidney Injury
    3. Critical Illness
    MeSH:Acute Kidney Injury Critical Illness Wounds and Injuries
    HPO:Acute kidney injury

    Primary Outcomes

    Description: As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria

    Measure: Incidence of any stage of acute kidney injury

    Time: 14 days

    Secondary Outcomes

    Description: Mortality

    Measure: Mortality

    Time: 14-day, hospital, and intensive care unit (ICU) mortality

    Description: Defined by return of creatinine to < 1.5 times of baseline

    Measure: Renal recovery

    Time: 14 days

    Description: Percentage

    Measure: Percentage of patients who receive renal replacement therapy

    Time: 14 days

    Description: Percentage of participants who are dialysis dependent

    Measure: Percentage of participants who are dialysis dependent

    Time: Through study completion, an average of 90 days

    Description: Days without vasoactive medications and mechanical ventilation

    Measure: Free-days of vasoactive medications and mechanical ventilation

    Time: Day 30

    Description: 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 days

    Description: 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 days

    Description: 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 days
    16 Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units

    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

    NCT04459975
    Conditions
    1. on Occurrence of Acurate Kidney Injury During Intensive Care Unit
    2. Abnormalities of Urinary Analysis
    Interventions
    1. Other: Non interventional study
    MeSH:Acute Kidney Injury Wounds and Injuries
    HPO:Acute kidney injury

    Primary Outcomes

    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 months
    17 SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative

    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.

    NCT04466306
    Conditions
    1. Acute Kidney Injury
    2. COVID
    MeSH:Acute Kidney Injury Wounds and Injuries
    HPO:Acute kidney injury

    Primary Outcomes

    Description: Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output

    Measure: Acute Kidney Injury (AKI)

    Time: 14 days

    Secondary Outcomes

    Description: Survival to ICU discharge or Day 14

    Measure: Survival

    Time: 14 days

    Description: The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy

    Measure: 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 weight

    Measure: Fluid overload

    Time: Day of Enrollment

    Description: The exposure of enrolled patients to known nephrotoxic medications, including diuretics

    Measure: Rate of nephrotoxic medication exposure

    Time: Day of Enrollment
    18 CoV-Hep Study: Randomized and Paired Clinical Trial Comparing Regional Anticoagulation Modalities in Continuous Venous Venous Hemodialysis in Patients With COVID-19

    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.

    NCT04487990
    Conditions
    1. Acute Kidney Injury
    2. Covid19
    Interventions
    1. Drug: unfractionated Heparin
    MeSH:Acute Kidney Injury
    HPO:Acute kidney injury

    Primary Outcomes

    Description: The percentage of clotted dialyzers within 72 hours in each of the studied groups.

    Measure: Clotted dialyzers

    Time: Day 3 of dialysis

    Secondary Outcomes

    Description: Number of hours until a dialyzer clots in the first 72 hours of dialysis

    Measure: Time-free of clotting

    Time: Day 3 of dialysis

    Description: The amount of dialyzers used in the first 72 hours of hemodialysis

    Measure: Number of dialyzers used

    Time: Day 3 of dialysis

    Description: Variation in dialysis system and vascular access pressures in the first 72 h of dialysis

    Measure: Pressure variation

    Time: Day 3 of dialysis

    Description: Variation in urea sieving between the first, second and third days of dialysis

    Measure: Urea sieving

    Time: Day 3 of dialysis

    Description: Time of dialysis stop due to clotting in the first 72 hours

    Measure: Downtime of dialysis

    Time: Day 3 of dialysis
    19 A Prospective, Double-Blind, Placebo-controlled Study of Suramin in Subjects With Furosemide-Resistant Acute Kidney Injury (AKI): Efficacy in Preventing Dialysis Dependent AKI

    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.

    NCT04496596
    Conditions
    1. Acute Kidney Injury
    Interventions
    1. Drug: Suramin
    2. Drug: Placebo
    MeSH:Acute Kidney Injury
    HPO:Acute kidney injury

    Primary Outcomes

    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
    20 Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization

    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.

    NCT04530448
    Conditions
    1. COVID
    2. Coronavirus
    3. Coronavirus Infection
    4. AKI
    5. Acute Kidney Injury
    Interventions
    1. Drug: Sodium bicarbonate
    2. Other: Standard of Care
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Acute Kidney Injury Wounds and Injuries
    HPO:Acute kidney injury

    Primary Outcomes

    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

    Secondary Outcomes

    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 days

    Measure: Vent-Free

    Time: 28 days

    Description: Hospital-free days to 60 days

    Measure: Hospital-Free

    Time: 60 days post-index hospitalization
    21 Renin and Renal Biomarker Response to Angiotensin II Versus Controls in Septic Shock: An Open-Label Study

    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.

    NCT04558359
    Conditions
    1. Septic Shock
    2. Acute Kidney Injury
    Interventions
    1. Other: Standard of Care
    2. Drug: Angiotensin II
    MeSH:Shock, Septic Acute Kidney Injury
    HPO:Acute kidney injury

    Primary Outcomes

    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)

    Secondary Outcomes

    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 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 admission

    Measure: In-hospital mortality

    Time: Up to 3 months following enrollment

    Description: Days free of renal replacement therapy from enrollment up to day 28

    Measure: Renal replacement therapy-free days

    Time: Within 28 days of enrollment

    Description: 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 enrollment
    22 C5 Complement Inhbition Using Ravulizumab for the Treatment of COVID-19 Induced Thrombotic Microangiopathy

    Ultomiris (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.

    NCT04570397
    Conditions
    1. Covid19
    2. Thrombotic Microangiopathies
    3. Acute Kidney Injury
    Interventions
    1. Drug: Ravulizumab
    MeSH:Acute Kidney Injury Thrombotic Microangiopathies
    HPO:Acute kidney injury

    Primary Outcomes

    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 days

    Secondary Outcomes

    Description: 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 days
    23 Regional Epidemiology of COVID-19 and Acute Kidney Injury in England

    The 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.

    NCT04579562
    Conditions
    1. Acute Kidney Injury
    Interventions
    1. Other: No intervention
    MeSH:Acute Kidney Injury
    HPO:Acute kidney injury

    Primary Outcomes

    Description: In-hospital all cause mortality in patients with acute kidney injury and COVID-19

    Measure: All-cause mortality

    Time: 30 days

    Description: Incidence of acute kidney injury in patients with COVID-19

    Measure: acute kidney injury

    Time: 30 days

    Secondary Outcomes

    Description: Need for mechanical ventilation in patients with COVID-19

    Measure: Mechanical ventilation

    Time: 30 days
    24 Extracorporeal Blood Purification Therapy in Critically Ill Patients: an Interactive,Web-based,Multicenter,Observational Prospective Registry

    Worldwide, 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.

    NCT04580680
    Conditions
    1. Critical Illness
    2. Acute Kidney Injury
    3. Sepsis
    4. Systemic Inflammatory Response Syndrome
    Interventions
    1. Device: Commercial membrane for Extracorporeal Blood Purification Therapy (EBPT)
    MeSH:Acute Kidney Injury Critical Illness Systemic Inflammatory Response Syndrome
    HPO:Acute kidney injury

    Primary Outcomes

    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) initiation

    Secondary Outcomes

    Description: 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 initiation

    Description: 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 initiation

    Description: 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 initiation

    Description: 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 initiation

    Description: 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 initiation

    Description: 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 initiation

    Description: 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 initiation

    Description: 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 initiation

    Description: 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 initiation

    Description: 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 initiation
    25 Long-term Outcomes After Acute Kidney Injury in Coronavirus Disease (COVID-19)

    This 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).

    NCT04583293
    Conditions
    1. Acute Kidney Injury
    Interventions
    1. Other: No intervention
    MeSH:Acute Kidney Injury Wounds and Injuries
    HPO:Acute kidney injury

    Primary Outcomes

    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.

    Secondary Outcomes

    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.
    26 Long-term Outcomes After Acute Kidney Injury in Coronavirus Disease (COVID-19) as Determined by Multiparametric Magnetic Resonance Imaging (MRI)

    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).

    NCT04594291
    Conditions
    1. Acute Kidney Injury
    Interventions
    1. Procedure: MRI scans
    MeSH:Acute Kidney Injury Wounds and Injuries
    HPO:Acute kidney injury

    Primary Outcomes

    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 months

    Description: 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 months

    Description: 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 months

    Secondary Outcomes

    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.

    Time: 3-6 and 24 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: 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 months

    Description: Recording of the number of participants who developed any cardiovascular events.

    Measure: Incidence of cardiovascular events.

    Time: 3-6, 12 and 24 months

    Description: 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 months
    27 Role of Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Cystatin C in Prediction of Acute Kidney Injury in Patients With Covid-19 Infection

    Recent 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.

    NCT04603664
    Conditions
    1. Biochemical Markers ,NGAL,Cystatin c, Acute Kidneyinjury, Covid 19
    Interventions
    1. Diagnostic Test: serum NGAL and cystatin c
    MeSH:Acute Kidney Injury
    HPO:Acute kidney injury

    Primary Outcomes

    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 admission

    Secondary Outcomes

    Description: 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 admission
    28 Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury

    Multiple 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.

    NCT04633889
    Conditions
    1. Acute Kidney Injury
    Interventions
    1. Drug: Deferoxamine
    2. Drug: Normal saline
    MeSH:Acute Kidney Injury Wounds and Injuries
    HPO:Acute kidney injury

    Primary Outcomes

    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 days

    Secondary Outcomes

    Description: Urine levels of NGAL and KIM-1

    Measure: Renal tubular injury

    Time: 3 days

    Description: Peak postoperative troponin I elevation >10 times the 99th percentile upper reference limit

    Measure: Postoperative myocardial injury

    Time: 2 days

    Description: New onset postoperative atrial fibrillation (patients with atrial fibrillation at baseline will be excluded)

    Measure: Atrial fibrillation

    Time: 7 days

    Description: Requirement for mechanical ventilation >24h postoperatively

    Measure: Prolonged mechanical ventilation

    Time: 24 hours

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days
    29 Plasma Exchange (PLEX) and Convalescent Plasma (CCP) in COVID-19 Patients With Multiorgan Failure - the COVID PLEX+CCP Trial

    This 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.

    NCT04634422
    Conditions
    1. Respiratory Failure
    2. Renal Failure, Acute
    Interventions
    1. Procedure: Plasma exchange and convalescent plasma
    MeSH:Respiratory Insufficiency Acute Kidney Injury Multiple Organ Failure
    HPO:Acute kidney injury

    Primary Outcomes

    Description: The primary outcome is days alive and out of hospital from randomisation to day 90.

    Measure: Alive at Day 90th

    Time: 90 days

    Secondary Outcomes

    Description: 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 days

    Description: All-cause mortality at day 28

    Measure: Day 28 all cause mortality

    Time: 28 days

    Description: Days alive without life support at day 90

    Measure: Days alive without life support at day 90

    Time: 90 days

    HPO Nodes


    Reports

    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.

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