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

NCT04459975 | Unknown

• 1 other identifier: CoV-AKI_2020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.To describe incidence, severity and mortality associated with AKI during covid-19 infection in ICU
2. 2.To identify specific risk factors for AKI
3. 3.To explore pathophysiologic mechanism of AKI during COVID-19 infection

Conditions

on Occurrence of Acurate Kidney Injury During Intensive Care Unit; Abnormalities of Urinary Analysis

Keywords

Acurate Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

Non interventional study OTHER

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

AKI (+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Intensive care units attached to the Hospices Civils de Lyon (HCL)

Lyon, 69002, France

RECRUITING

Central Study Contacts

Denis FOUQUE, Professor

CONTACT

+33 472 678 704; denis.fouque@chu-lyon.fr

Maxime ESPI

CONTACT

+33 472 678 704; maxime.espi@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: July 7, 2020
• Study Start: April 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

FR (1)