CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 367 enrolled
Drug / intervention
Relative section +1 moreother
Likely dose
Not stated in record
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Search/NCT05041023
NCT05041023N/ACompleted

Experience of Relatives and Caregivers of Death in ICU After the Withdrawal of Life-sustaining Therapies, Associated With an Organ Procurement Procedure (Controlled Donation After Circulatory Death).

Assistance Publique - Hôpitaux de Paris·observational·Posted Sep 10, 2021·Updated Jan 15, 2025

In Brief

An observational study evaluating Relative section and Caregiver section for Death, Assisted and 2 related conditions. Completed, enrolled 367 participants across 1 site.

Detailed Summary

Controlled donation after circulatory death (cDCD) refers to organ donation (OD) from patients whose death is defined using circulatory criteria and from whom circulatory death occurs after a planned withdrawal of life-sustaining therapies (WLST) in intensive care units (ICUs). During cDCD, the patient is still alive while OD process is being discussed and organized. Caregivers can be particularly uncomfortable in this scenario. In the specific context of cDCD, developing knowledge on the perceptions and experiences of relatives and ICU caregivers regarding OD is crucial but remains poorly investigated. Investigators propose to conduct a prospective multicentric observational research to better understand relatives' and ICU caregivers' experience of cDCD. Better understanding their perceptions and experiences will enable to develop interventions to support and guide them throughout this practice.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 10, 2021
Enrollment StartOct 27, 2021
Primary CompletionMay 20, 2024
Study CompletionSep 13, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 4.8 years ago

Interventions

Relative sectionother

Relatives are assessed by phone calling with an experienced psychologist at 3 and 6 months after patient's death. Relatives answer to self-questionnaire and 3 scales. Furthermore, 20 of them are offered to participate in a semi-structured interview with an experienced psychologist, within 6 months to 1 year following the patient's death.

Caregiver sectionother

Caregivers are self-evaluated within 72 hours after death by questionnaire survey, whose results will remain confidential to the center that included the situation. Furthermore, 20 of them (10 medical staff and 10 paramedical staff and / or until saturation) are offered to participate in a semi-structured interview with an experienced psychologist.