Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units

• Conditions: on Occurrence of Acurate Kidney Injury During Intensive Care Unit; Abnormalities of Urinary Analysis
• Interventions: Other: Non interventional study

• Registration Number: NCT04459975
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-06-12
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-06
• Last Update Submitted: 2020-07-06
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07
• Primary Completion: 2020-10
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Confirmed COVID-19 infection (by qRT-PCR and/or TDM typical lesion)
• Needing intensive care

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Exclusion Criteria

• End Stage Renal Disease patients (with pre-existent dialysis)
• Intensive care support for less than 72h (transfer in conventional unit or death)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AKI (+)	Non interventional study	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).

Primary Outcome Measures

Name	Time	Method
Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection	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

Trial Locations

Locations (1)

Intensive care units attached to the Hospices Civils de Lyon (HCL); 🇫🇷 Lyon, France