Renal Recovery After PEEP Weaning in ARDS (RE2SDRA) (RE2SDRA)

December 23, 2024 updated by: University Hospital, Brest

Renal Recovery After PEEP Weaning in ARDS

The purpose of the study is to investigate renal recovery in ARDS after PEEP weaning. The primary outcome was the variation of the hourly urine output (HUO), 48 h after PEEP weaning. Secondary outcomes were the need for RRT and mortality. Two groups were defined depending wether hourly urine output was greater or lower than 0.35 mL/kg/h.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

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
      • Brest, France, 29200
        • CHU Brest

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients were included if they were intubated for more than 48 hours, exposed to a PEEP≥ 8 cmH20 followed by a successful PEEP weaning defined as ≤6 cmH20 for more than 72 hours.

Patients were excluded if they had chronic end-stage renal disease on admission, refusal to participate, whose non-opposition could not be obtained from themselves or their trusted support person in the event of incapacity or if they were under legal protection.

Patients with impaired hourly urine output (HUO) (≤ 1 ml/kg/h) before PEEP weaning were selected.

Therefore, 120 patients of a cohort of 338 who required invasive mechanical ventilation for ARDS in the ICU of the Brest University Hospital were included.

The ethics committee of Brest university hospital approved the investigation RE2SDRA on 03/14/2024.

No additional diagnostic, treatment or monitoring procedures were conducted.

Description

Inclusion Criteria:

  • intubated for more than 48 hours, exposed to a PEEP≥ 8 cmH20

Exclusion Criteria:

  • chronic end-stage renal disease on admission
  • refusal to participate
  • non-opposition could not be obtained from themselves or their trusted support person in the event of incapacity
  • under legal protection.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of the hourly urine output on day 2 after PEEP weaning
Time Frame: From enrollement to day 2 after PEEP weaning
Variation of the hourly urine output on day 2 after PEEP weaning
From enrollement to day 2 after PEEP weaning

Collaborators and Investigators

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

Sponsor

University Hospital, Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

March 21, 2024

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC24.0031 - RE2SDRA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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