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Clinical Trials in France / NCT05625867
Recruiting Not applicable

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

NCT05625867 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire Dijon
Phase
Not applicable
Started
2023-02-05
Last updated
2024-11-05

Condition(s) studied

Post Intensive Care Syndrome

Investigational drug(s) / intervention(s)

Psychological and quality of life questionnairesInterdisciplinary consultation at 4/5 months

Psychological and quality of life questionnaires: At 4/5 months and at 9 months

Interdisciplinary consultation at 4/5 months: About ten days after the questionnaires were administered

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • MOS SF-36 Quality of Life Scale Score — Between 4/5 and 9 months after discharge from intensive care

Trial sites (1)

FacilityCityRegionStatus
Chu Dijon Bourgogne Dijon France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05625867 on ClinicalTrials.gov ↗ ← All trials in France