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

Study Overview

• Status: Unknown
• Conditions: on Occurrence of Acurate Kidney Injury During Intensive Care Unit; Abnormalities of Urinary Analysis
• Intervention / Treatment: Other: Non interventional study

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Denis FOUQUE, Professor; Phone Number: +33 472 678 704; Email: denis.fouque@chu-lyon.fr
• Study Contact Backup: Name: Maxime ESPI; Phone Number: +33 472 678 704; Email: maxime.espi@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69002
    • Recruiting
    • Intensive care units attached to the Hospices Civils de Lyon (HCL)
    • Contact: Denis FOUQUE, Professor; Phone Number: +33 472 678 704; Email: denis.fouque@chu-lyon.fr
    • Contact: Maxime EPSI; Phone Number: +33 472 678 704; Email: maxime.espi@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients supported in intensive care units for covid-19 infection

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AKI (-); patients treated in ICU for COVID-19 infection and without occurrence of AKI (define as creatinine > 1,5x baseline according with KDIGO guidelines)
AKI (+); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection	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	7 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Acurate Kidney Injury
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: CoV-AKI_2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No