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

NCT05699889 | Completed

• 1 other identifier: RCAPHM20_0177
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Acute Respiratory Distress Syndrome; Acute Kidney Injury Due to COVID-19

Outcome Measures

Primary Outcomes (1)

• Evaluation of the incidence of acute kidney injury and tubular dysfunction

  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

Study Arms (2)

Patients in intensive care for SARS-CoV 2 infection with severe respiratory impairment.

Other: Data collection

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

Other: Data collection

Interventions

Data collection OTHER

acute kidney injury and tubular dysfunction

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

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

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

You may qualify if:

• Displaying acute respiratory distress Needing invasive mechanical ventilation
• With PaO2/FiO2 ratio \< 300 after orotracheal intubation

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Emilie GARRIDO-PRADALIE

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

• Mickaël BOBOT

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: January 26, 2023
• Study Start: May 2, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Locations

FR (1)