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
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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TERMINATED
119 participants
OBSERVATIONAL
2012-06-15
2016-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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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
Assistance Publique - Hopitaux de Marseille
Marseille, , France
CHU Lapeyronie
Montpellier, , France
Hôpital Gui De Chauliac (CHU de Montpellier)
Montpellier, , France
Centre Hospitalier Universitaire de Nîmes
Nîmes, , France
Hôpital Kremlin Bicêtre - APHP
Paris, , France
Countries
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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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