Acute Kidney Dysfunction in COVID-19 and Non-COVID-19 Related ARDS (URICOV)

January 27, 2023 updated by: Assistance Publique Hopitaux De Marseille

Prevalence of COVID-19-associated Kidney Injury in ICU and Prognosis of Proximal Tubular Injury in ARDS: the URICOV Study

In addition to respiratory involvement, SARS-CoV 2, the virus responsible for coronavirus 2019 or Covid-19, appears to be responsible for renal involvement such as acute renal failure or proteinuria, so the mechanisms are not known at this time. The consequences of Covid-19 on renal function in the short and long term are not known.

It is important to be able to better document these renal impairments to understand the mechanisms of this disease.

The main objective of this study is to describe the prevalence of Covid-19-related renal damage (acute renal failure, proteinuria, microalbuminuria, hematuria) in a large cohort of patients in intensive care for SARS-CoV 2 infection with severe respiratory impairment.

The other objectives will be to evaluate in this cohort the impact of these renal impairments on the severity of the Covid-19 disease, and to compare them to the renal impairments of patients in intensive care for acute respiratory distress syndrome (ARDS) due to other respiratory diseases.

Blood and urine samples will be taken at the time of intubation in all critically ill patients with respiratory distress requiring mechanical ventilation for Covid-19 or other cause of respiratory distress with PaO2/FiO2 ratio < 300.

Patients will be followed for the duration of their ICU and hospital stay. Data will be collected prospectively in three ICUs in the University Hospitals of Marseille.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Patients in intensive care for SARS-CoV 2 infection with severe respiratory impairment and Patients in intensive care without SARS-CoV 2 infection with severe respiratory impairment

Description

Inclusion Criteria:

  • • Displaying acute respiratory distress Needing invasive mechanical ventilation

    • With PaO2/FiO2 ratio < 300 after orotracheal intubation

Exclusion Criteria:

  • Patients in ICU following thoracic surgery or lung transplantation
  • Patients with cardiogenic pulmonary oedema
  • Patients with end stage kidney disease
  • Moribund patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients in intensive care for SARS-CoV 2 infection with severe respiratory impairment.
Other: Data collection
acute kidney injury and tubular dysfunction
Patients in intensive care without SARS-CoV 2 infection with severe respiratory impairment.
Other: Data collection
acute kidney injury and tubular dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the incidence of acute kidney injury and tubular dysfunction
Time Frame: First 24 hours after orotracheal intubation
We aimed to perform a detailed analysis of urinary markers of kidney dysfunction with urine protein electrophoresis and tubular protein dosage in a prospective cohort of critically ill patients in ICU for ARDS due to COVID-19 in the first 24 hours following orotracheal intubation, to evaluate the incidence of acute kidney injury (AKI) and tubular dysfunction among critically ill patients with COVID-19-related ARDS at the onset of Mechanical ventilation, and to specify which part of the kidney parenchyma is involved.
First 24 hours after orotracheal intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Mickaël BOBOT, Assistance Publique Hopitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2020

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCAPHM20_0177

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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