Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units
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|ClinicalTrials.gov Identifier: NCT04459975|
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
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:
- To describe incidence, severity and mortality associated with AKI during covid-19 infection in ICU
- To identify specific risk factors for AKI
- To explore pathophysiologic mechanism of AKI during COVID-19 infection
|Condition or disease||Intervention/treatment|
|on Occurrence of Acurate Kidney Injury During Intensive Care Unit Abnormalities of Urinary Analysis||Other: Non interventional study|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units|
|Actual Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||November 2020|
patients treated in ICU for COVID-19 infection and without occurrence of AKI (define as creatinine > 1,5x baseline according with KDIGO guidelines)
patient treated in ICU for COVID-19 infection and with occurrence of AKI among which:
• Severe AKI patients (define as creatinine > 3x baseline or need for renal replacement therapy according with KDIGO guidelines) who will participate to biocollection and to post-mortem biopsy (if death).
Other: Non interventional study
Comorbidities, creatinine levels, urinary analysis, hemodynamic, respiratory status, co-medication will be collected from medical files for each patient.
Specific datas from patients with AKI will be collected from medical files For severe acute patients, serum and urinary analysis will performed to identify the underlying cause of kidney injury For severe AKI patients who will die, post-mortem renal biopsy will be performed, for histopathological analysis
- Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection [ Time Frame: 7 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459975
|Contact: Denis FOUQUE, Professor||+33 472 678 email@example.com|
|Contact: Maxime ESPI||+33 472 678 firstname.lastname@example.org|