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

Terminated

• Conditions: Stress Disorders, Post-Traumatic
• Interventions: Other: IES-R and HDAS scores

• Registration Number: NCT01412502
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Study Start: 2012-06-15
• Primary Completion: 2016-06-28
• Study Completion: 2016-06-28
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Limitation/cessation of active treatment	IES-R and HDAS scores	Participants in this group are the nearest relatives (or "person-of-trust") of a patient who has passed away within 3 days of admission to an intensive care unit. The cause of death includes limitation/cessation of active treatment without brain death.
Brain death with organ donation	IES-R and HDAS scores	Participants in this group are the nearest relatives (or "person-of-trust") of a patient who has passed away within 3 days of admission to an intensive care unit. The cause of death includes brain death with multiple organ donation +/- tissues.
Sudden death	IES-R and HDAS scores	Participants in this group are the nearest relatives (or "person-of-trust") of a patient who has passed away within 3 days of admission to an intensive care unit. The cause of death was 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.

Primary Outcome Measures

Name	Time	Method
IES-R > 37: yes/no	6 weeks	Impact of Event Scale score greater than 37: yes/no

Secondary Outcome Measures

Name	Time	Method
IES-R	6 weeks	Impact of Event scale score (score varying from 0 (no risk of post traumatic stress) to 88 (highest risk of post traumatic stress)).
HDAS score	6 weeks	Hospital Depression and Anxiety Score (varies from 0 to 21). A score \>8 indicates clinically significant anxiety/depression.

Trial Locations

Locations (6)

CHU Lapeyronie; 🇫🇷 Montpellier Cedex 05, France

Hôpital Beaujon -APHP; 🇫🇷 Clichy, France

Assistance Publique - Hopitaux de Marseille; 🇫🇷 Marseille, France

Hôpital Gui De Chauliac (CHU de Montpellier); 🇫🇷 Montpellier cedex 5, France

Hôpital Kremlin Bicêtre - APHP; 🇫🇷 Paris, France

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes cedex 09, France