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

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Completed
CT.gov ID
NCT05699889
Collaborator
(none)
130
1
28
4.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Data collection

Study Design

Study Type:
Observational
Actual Enrollment :
130 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence of COVID-19-associated Kidney Injury in ICU and Prognosis of Proximal Tubular Injury in ARDS: the URICOV Study
Actual Study Start Date :
May 2, 2020
Actual Primary Completion Date :
Sep 1, 2022
Actual Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the incidence of acute kidney injury and tubular dysfunction [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistance Publique Hopitaux de Marseille Marseille France

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Emilie GARRIDO-PRADALIE, Assistance Publique Hopitaux De Marseille
  • Principal Investigator: Mickaël BOBOT, Assistance Publique Hopitaux De Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT05699889
Other Study ID Numbers:
  • RCAPHM20_0177
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2023