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

Stress Disorders, Post-Traumatic research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Stress Disorders, Post-Traumatic

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:IES-R and HDAS scoresThe Impact of Event Scale and Hospital Depression and Anxiety Score questionnaires are administered to participants.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Brain death with organ donationParticipants 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.

Limitation/cessation of active treatmentParticipants 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.

Sudden deathParticipants 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.

Study Status

Unknown status

Start Date: June 2012

Completed Date: November 2015

Phase: N/A

Type: Observational

Design:

Primary Outcome: IES-R > 37: yes/no

Secondary Outcome: IES-R

Study sponsors, principal investigator, and references

Principal Investigator: Jean Yves Lefrant, MD PhD

Lead Sponsor: Centre Hospitalier Universitaire de NÄ«mes

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01412502

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