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Clinical Trials/NCT01412502
NCT01412502
Terminated
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes6 sites in 1 country119 target enrollmentJune 15, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Disorders, Post-Traumatic
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
119
Locations
6
Primary Endpoint
IES-R > 37: yes/no
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2012
End Date
June 28, 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

IES-R > 37: yes/no

Time Frame: 6 weeks

Impact of Event Scale score greater than 37: yes/no

Secondary Outcomes

  • IES-R(6 weeks)
  • HDAS score(6 weeks)

Study Sites (6)

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