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Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit

Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05625867
Acronym
COPRéa
Enrollment
404
Registered
2022-11-23
Start date
2023-02-05
Completion date
2026-05-31
Last updated
2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Intensive Care Syndrome

Brief 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. 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.

Interventions

OTHERPsychological and quality of life questionnaires

At 4/5 months and at 9 months

OTHERInterdisciplinary consultation at 4/5 months

About ten days after the questionnaires were administered

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * Pregnant, parturient or breastfeeding women * Patient incarcerated * Patient with a psychiatric history

Design outcomes

Primary

MeasureTime frame
MOS SF-36 Quality of Life Scale ScoreBetween 4/5 and 9 months after discharge from intensive care

Countries

France

Contacts

Primary ContactAlexandra LAURENT
alexandra.laurent@u-bourgogne.fr03 80 39 39 77

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026