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Clinical Trials/NCT05625867
NCT05625867
Recruiting
N/A

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

Centre Hospitalier Universitaire Dijon1 site in 1 country256 target enrollmentFebruary 5, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post Intensive Care Syndrome
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
256
Locations
1
Primary Endpoint
MOS SF-36 Quality of Life Scale Score
Status
Recruiting
Last Updated
last year

Overview

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.
Registry
clinicaltrials.gov
Start Date
February 5, 2023
End Date
May 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

MOS SF-36 Quality of Life Scale Score

Time Frame: Between 4/5 and 9 months after discharge from intensive care

Study Sites (1)

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