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

NCT ID: NCT01412502

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-15

Study Completion Date

2016-06-28

Brief Summary

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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.

Detailed Description

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Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

IES-R and HDAS scores

Intervention Type OTHER

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.

IES-R and HDAS scores

Intervention Type OTHER

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.

IES-R and HDAS scores

Intervention Type OTHER

The Impact of Event Scale and Hospital Depression and Anxiety Score questionnaires are administered to participants.

Interventions

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IES-R and HDAS scores

The Impact of Event Scale and Hospital Depression and Anxiety Score questionnaires are administered to participants.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Yves Lefrant, MD PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Caroline Boutin, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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Hôpital Beaujon -APHP

Clichy, , France

Site Status

Assistance Publique - Hopitaux de Marseille

Marseille, , France

Site Status

CHU Lapeyronie

Montpellier, , France

Site Status

Hôpital Gui De Chauliac (CHU de Montpellier)

Montpellier, , France

Site Status

Centre Hospitalier Universitaire de Nîmes

Nîmes, , France

Site Status

Hôpital Kremlin Bicêtre - APHP

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2009-A00848-49

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC-N/2009/CB-01

Identifier Type: -

Identifier Source: org_study_id

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