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 Intensive Care Syndrome Clinical Trial

— COPRéa  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625867
• Other study ID #: LAURENT UB 2022
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2023
• Est. completion date: May 2026

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Alexandra LAURENT
• Phone: 03 80 39 39 77
• Email: alexandra.laurent[@]u-bourgogne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Intensive Care Syndrome

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MOS SF-36 Quality of Life Scale Score		Between 4/5 and 9 months after discharge from intensive care