NCT01412502

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

Terminated Last updated 3 January 2018

What this trial tests

trial testing IES-R and HDAS scores in Stress Disorders, Post-Traumatic in 119 participants. Terminated before completion.

Timeline

15 June 2012

Primary endpoint
28 June 2016

28 June 2016

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nīmes
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	119
Start date	15 June 2012
Primary completion	28 June 2016
Estimated completion	28 June 2016
Sites	6 locations across France

Drugs / interventions tested

• IES-R and HDAS scores

Conditions studied

• Stress Disorders, Post-Traumatic — all drugs for Stress Disorders, Post-Traumatic →

Sponsor

Centre Hospitalier Universitaire de Nīmes

Who can join

18 and older, any sex, with Stress Disorders, Post-Traumatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.