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Post Traumatic Stress Among Relatives of Brain-dead, Withdrawal of Life Support, and Sudden Death Patients

Evaluation of Post Traumatic Stress Among the Nearest Relatives of Brain-dead, Withdrawal of Life Support, and Sudden Death Patients

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01412502
Enrollment
119
Registered
2011-08-09
Start date
2012-06-15
Completion date
2016-06-28
Last updated
2018-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post-Traumatic

Keywords

Tissue Donors, Tissue and Organ Procurement, Brain death, Withdrawal of life support

Brief summary

This study concerns the nearest relatives of patients who have passed away within 3 days of admission to an ICU due to: (1) brain death with multiple organ donation +/- tissues or (2) death via limitation and / or cessation of active treatment (LATA) without brain death or (3) sudden death of a previously healthy patient (no physical or mental limitations; MacCabe score = 0) within 3 days of admission to ICU without LATA nor brain death. Our primary objective is to determine the proportion of nearest relatives at risk for post traumatic stress disorder as defined by an Impact of Event Scale score greater than 37, and to compare this factor between the three above-mentioned groups.

Interventions

OTHERIES-R and HDAS scores

The Impact of Event Scale and Hospital Depression and Anxiety Score questionnaires are administered to participants.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participants are the nearest relatives (or person-of-trust) of a patient who has passed away in an intensive care unit (ICU). The cause of death must fall into 1 of the following three categories: (1) brain death with multiple organ donation +/- tissues; (2) death via limitation and / or cessation of active treatment (LATA) without brain death; (3) sudden death of a previously healthy patient (no physical or mental limitations; MacCabe score = 0) within 3 days of admission to ICU without LATA nor brain death * The participant must be one of the following (roman numerals indicate prioritization in choice of participants, if needed): (i) designated person-of-trust; (ii) spouse/partner of the deceased; (iii) parent of the deceased; (iv) child of the deceased; (v) sibling of the deceased.

Exclusion criteria

* Patient deceased after 3 days of ICU care without LATA * The deceased was under 18 years old * The deceased was over 70 years old * Refusal to participated * Participant does not speak French * The participant is under judicial protection, under tutorship or curatorship * The participant is deaf or mute * The deceased has no nearest relative

Design outcomes

Primary

MeasureTime frameDescription
IES-R > 37: yes/no6 weeksImpact of Event Scale score greater than 37: yes/no

Secondary

MeasureTime frameDescription
IES-R6 weeksImpact of Event scale score (score varying from 0 (no risk of post traumatic stress) to 88 (highest risk of post traumatic stress)).
HDAS score6 weeksHospital Depression and Anxiety Score (varies from 0 to 21). A score \>8 indicates clinically significant anxiety/depression.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026