Post Intensive Care SyndromeCOPRéaNCT05625867
Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit
A study testing Psychological and quality of life questionnaires and Interdisciplinary consultation at 4/5 months in people with Post Intensive Care Syndrome, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
A patient's stay in the ICU is not without consequences and can cause various physical and/or psychological sequelae such as anxiety, depression, post-traumatic stress disorder (PTSD), physical weakness and memory problems. These sequelae are grouped under the name "post intensive care syndrome" or PICS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Syndrome
- What is being tested?
- Psychological and quality of life questionnaires and Interdisciplinary consultation at 4/5 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2023to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person who has given oral consent
- Patient 18 years of age or older
- Patient with at least one organ failure
- Patient with a stay of 6 days or more
Who cannot join
- Person who is not affiliated or not a beneficiary of a social security system
- Patient at the end of his/her life
- Patient who does not speak French
- Minor (< 18 years old)
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to a legal protection measure
Show all 9Show fewer
- Pregnant, parturient or breastfeeding women
- Patient incarcerated
- Patient with a psychiatric history
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon
Alexandra LAURENT, 03 80 39 39 77, alexandra.laurent@u-bourgogne.fr
About this study
A patient's stay in the ICU is not without consequences and can cause various physical and/or psychological sequelae such as anxiety, depression, post-traumatic stress disorder (PTSD), physical weakness and memory problems. These sequelae are grouped under the name "post intensive care syndrome" or PICS.
Numerous studies have shown that PICS affects 50-70% of patients; however, very few studies have been conducted on the medical and psychological support devices needed for these patients following their hospitalization. Despite recommendations to set up an early and specific rehabilitation program, post-resuscitation consultations are not very frequent in France. The aim of the study is to measure the impact of an interdisciplinary post-resuscitation consultation on the quality of life of patients who have stayed more than 6 days in an intensive care unit.
Read more
All patients who agreed to participate will be followed for a period of 9 months after discharge from the ICU.
One month after discharge from the ICU, the patients will be randomly assigned to
- either in the "intervention" group who will benefit from an interdisciplinary post resuscitation consultation 4/5 months after their discharge from the intensive care unit
- or in the "control" group without post resuscitation consultation. They will all be contacted at 4/5 and 9 months to complete psychological and quality of life questionnaires.
- Conditions
- Post Intensive Care Syndrome
- Being tested
- Psychological and quality of life questionnaires, Interdisciplinary consultation at 4/5 months
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological and quality of life questionnairesOther
At 4/5 months and at 9 months
Interdisciplinary consultation at 4/5 monthsOther
About ten days after the questionnaires were administered
| Study group | Role | What they receive |
|---|---|---|
| Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU | Experimental | Not described Receives: Other: Psychological and quality of life questionnaires; Other: Interdisciplinary consultation at 4/5 months |
| Patient managed under standard practice conditions | Active comparator | Not described Receives: Other: Psychological and quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOS SF-36 Quality of Life Scale Score
Measured: Between 4/5 and 9 months after discharge from intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start5 Feb 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625867
- Sponsor's protocol ID
- LAURENT UB 2022
- Acronym
- COPRéa
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2022
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05625867
- Acronym / sponsor ID
- COPRéa / LAURENT UB 2022
- Conditions
- Post Intensive Care Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 23 Nov 2022 (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.
A patient's stay in the ICU is not without consequences and can cause various physical and/or psychological sequelae such as anxiety, depression, post-traumatic stress disorder (PTSD), physical weakness and memory problems. These sequelae are grouped under the name "post intensive care syndrome" or PICS.
Numerous studies have shown that PICS affects 50-70% of patients; however, very few studies have been conducted on the medical and psychological support devices needed for these patients following their hospitalization. Despite recommendations to set up an early and specific rehabilitation program, post-resuscitation consultations are not very frequent in France. The aim of the study is to measure the impact of an interdisciplinary post-resuscitation consultation on the quality of life of patients who have stayed more than 6 days in an intensive care unit.
All patients who agreed to participate will be followed for a period of 9 months after discharge from the ICU.
One month after discharge from the ICU, the patients will be randomly assigned to
- either in the "intervention" group who will benefit from an interdisciplinary post resuscitation consultation 4/5 months after their discharge from the intensive care unit
- or in the "control" group without post resuscitation consultation. They will all be contacted at 4/5 and 9 months to complete psychological and quality of life questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU | Experimental | Other: Psychological and quality of life questionnaires, Other: Interdisciplinary consultation at 4/5 months |
| Patient managed under standard practice conditions | Active comparator | Other: Psychological and quality of life questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Person who has given oral consent
- Patient 18 years of age or older
- Patient with at least one organ failure
- Patient with a stay of 6 days or more
Key exclusion criteria (9 listed)
- Person who is not affiliated or not a beneficiary of a social security system
- Patient at the end of his/her life
- Patient who does not speak French
- Minor (< 18 years old)
- Person subject to a legal protection measure (curatorship, guardianship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological and quality of life questionnairesAt 4/5 months and at 9 months | Other | Patient managed under standard practice conditions, Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU |
| Interdisciplinary consultation at 4/5 monthsAbout ten days after the questionnaires were administered | Other | Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU |
Primary outcome
MOS SF-36 Quality of Life Scale Score
Time frame: Between 4/5 and 9 months after discharge from intensive care
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological and quality of life questionnaires and Interdisciplinary consultation at 4/5 months in people with Post Intensive Care Syndrome, run by Centre Hospitalier Universitaire Dijon 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 5 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra LAURENT (03 80 39 39 77, alexandra.laurent@u-bourgogne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOS SF-36 Quality of Life Scale Score (time frame: Between 4/5 and 9 months after discharge from intensive care). 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 5 Nov 2024.