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

NCT ID: NCT05625867

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-05

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post Intensive Care Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU

Group Type EXPERIMENTAL

Psychological and quality of life questionnaires

Intervention Type OTHER

At 4/5 months and at 9 months

Interdisciplinary consultation at 4/5 months

Intervention Type OTHER

About ten days after the questionnaires were administered

Patient managed under standard practice conditions

Group Type ACTIVE_COMPARATOR

Psychological and quality of life questionnaires

Intervention Type OTHER

At 4/5 months and at 9 months

Interventions

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Psychological and quality of life questionnaires

At 4/5 months and at 9 months

Intervention Type OTHER

Interdisciplinary consultation at 4/5 months

About ten days after the questionnaires were administered

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Alexandra LAURENT

Role: CONTACT

03 80 39 39 77

Facility Contacts

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Alexandra LAURENT

Role: primary

03 80 39 39 77

Other Identifiers

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LAURENT UB 2022

Identifier Type: -

Identifier Source: org_study_id

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