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NCT Number: NCT05625867

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 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological and quality of life questionnaires

Other

At 4/5 months and at 9 months

Interdisciplinary consultation at 4/5 months

Other

About ten days after the questionnaires were administered

Primary outcomes

  1. MOS SF-36 Quality of Life Scale Score

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra LAURENT

CONTACT

[email protected]

03 80 39 39 77

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: COPRéa

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 23, 2022
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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