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

Purpose

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.

Condition	Intervention
Stress Disorders, Post-Traumatic	Other: IES-R and HDAS scores

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Evaluation of Post Traumatic Stress Among the Nearest Relatives of Brain-dead, Withdrawal of Life Support, and Sudden Death Patients

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:

IES-R > 37: yes/no [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Impact of Event Scale score greater than 37: yes/no

Secondary Outcome Measures:

IES-R [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Hospital Depression and Anxiety Score (varies from 0 to 21). A score >8 indicates clinically significant anxiety/depression.

Estimated Enrollment:	294
Study Start Date:	June 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412502

Contacts

Contact: Jean Yves Lefrant, MD PhD	+33.(0)4.66.68.30.50	jean.yves.lefrant@chu-nimes.fr
Contact: Carey Suehs, PhD	+33.(0)4.66.68.67.88	carey.suehs@chu-nimes.fr

Locations

France
Hôpital Beaujon -APHP	Not yet recruiting
Clichy, France
Sub-Investigator: Pierre Trouiller, MD
Sub-Investigator: Claire Bonneville, MD
Assistance Publique - Hopitaux de Marseille	Not yet recruiting
Marseille, France
Sub-Investigator: Marc Léone, MD PhD
CHU Lapeyronie	Recruiting
Montpellier Cedex 05, France, 34295
Sub-Investigator: Amaru Priscilla, MD
Hôpital Gui De Chauliac (CHU de Montpellier)	Recruiting
Montpellier cedex 5, France, 34295
Sub-Investigator: Florence Vachiéry-Lahaye, MD
Centre Hospitalier Universitaire de Nîmes	Recruiting
Nîmes cedex 09, France, 30029
Sub-Investigator: Jean Yves Lefrant, MD PhD
Principal Investigator: Caroline Boutin, MD
Sub-Investigator: Laurent Muller, MD
Hôpital Kremlin Bicêtre - APHP	Not yet recruiting
Paris, France
Sub-Investigator: Jacques Duranteau, MD PhD

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Study Director:	Jean Yves Lefrant, MD PhD	Centre Hospitalier Universitaire de Nîmes
Principal Investigator:	Caroline Boutin, MD	Centre Hospitalier Universitaire de Nîmes

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:	NCT01412502 History of Changes
Other Study ID Numbers:	PHRC-N/2009/CB-01, 2009-A00848-49
Study First Received:	August 8, 2011
Last Updated:	March 26, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:

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

Additional relevant MeSH terms:

Brain Death
Death, Sudden
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma

Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013