ARDS (Acute Respiratory Distress Syndrome)RE2SDRANCT06754787
Renal Recovery After PEEP Weaning in ARDS (RE2SDRA)
An observational study of ARDS (Acute Respiratory Distress Syndrome) and AKI - Acute Kidney Injury, run by University Hospital, Brest at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome), AKI - Acute Kidney Injury
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2024to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- intubated for more than 48 hours, exposed to a PEEP≥ 8 cmH20
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Medical subject headings
- Acute Lung Injury, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the hourly urine output on day 2 after PEEP weaning
Variation of the hourly urine output on day 2 after PEEP weaning
Measured: From enrollement to day 2 after PEEP weaning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start21 Mar 2024
- Primary completion1 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754787
- Sponsor's protocol ID
- 29BRC24.0031 - RE2SDRA
- Acronym
- RE2SDRA
- Status last verified
- Oct 2024
- First submitted
- 11 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Recovery After PEEP Weaning in ARDS
- ClinicalTrials.gov ID
- NCT06754787
- Acronym / sponsor ID
- RE2SDRA / 29BRC24.0031 - RE2SDRA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- intubated for more than 48 hours, exposed to a PEEP≥ 8 cmH20
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS (Acute Respiratory Distress Syndrome) and AKI - Acute Kidney Injury, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the hourly urine output on day 2 after PEEP weaning (time frame: From enrollement to day 2 after PEEP weaning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.