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

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.

Study Overview

• Status: Terminated
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Other: IES-R and HDAS scores

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• France
  • Clichy, France
    • Hôpital Beaujon -APHP
  • Marseille, France
    • Assistance Publique - Hopitaux de Marseille
  • Montpellier Cedex 05, France, 34295
    • CHU Lapeyronie
  • Montpellier cedex 5, France, 34295
    • Hôpital Gui De Chauliac (CHU de Montpellier)
  • Nîmes cedex 09, France, 30029
    • Centre Hospitalier Universitaire de Nîmes
  • Paris, France
    • Hôpital Kremlin Bicêtre - APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants are the nearest relatives (or "person-of-trust") of a patient who has passed away in an intensive care unit (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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brain death with organ donation; 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.	Other: IES-R and HDAS scores; The Impact of Event Scale and Hospital Depression and Anxiety Score questionnaires are administered to participants.
Limitation/cessation of active treatment; 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.	Other: IES-R and HDAS scores; The Impact of Event Scale and Hospital Depression and Anxiety Score questionnaires are administered to participants.
Sudden death; 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.	Other: IES-R and HDAS scores; The Impact of Event Scale and Hospital Depression and Anxiety Score questionnaires are administered to participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IES-R > 37: yes/no	Impact of Event Scale score greater than 37: yes/no	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Jean Yves Lefrant, MD PhD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2012
• Primary Completion (ACTUAL): June 28, 2016
• Study Completion (ACTUAL): June 28, 2016

Study Registration Dates

• First Submitted: August 8, 2011
• First Submitted That Met QC Criteria: August 8, 2011
• First Posted (ESTIMATE): August 9, 2011

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Brain death; Tissue Donors; Tissue and Organ Procurement; Withdrawal of life support
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Trauma and Stressor Related Disorders; Death; Unconsciousness; Consciousness Disorders; Coma; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Brain Death; Death, Sudden
• Other Study ID Numbers: PHRC-N/2009/CB-01; 2009-A00848-49 (OTHER: RCB number)