Clinical trial NCT01412502: Post Traumatic Stress Among Relatives of Brain-dead, Withdrawal of Life Support, and Sudden Death Patients
Official title: Evaluation of Post Traumatic Stress Among the Nearest Relatives of Brain-dead, Withdrawal of Life Support, and Sudden Death Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stress Disorders, Post-Traumatic
Keywords: Tissue Donors
Tissue and Organ Procurement
Brain death
Withdrawal of life support
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: IES-R > 37: yes/no
timeFrame: 6 weeks
Secondary outcomes:
measure: IES-R
timeFrame: 6 weeks
measure: HDAS score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital Beaujon -APHP
city: Marseille
country: France
facility: Assistance Publique - Hopitaux de Marseille
city: Montpellier Cedex 05
country: France
facility: CHU Lapeyronie
city: Montpellier cedex 5
country: France
facility: Hôpital Gui De Chauliac (CHU de Montpellier)
city: Nîmes cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
city: Paris
country: France
facility: Hôpital Kremlin Bicêtre - APHP
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean Yves Lefrant, MD PhD
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Caroline Boutin, MD
role: PRINCIPAL_INVESTIGATOR
References: