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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01412502
• Other study ID #: PHRC-N/2009/CB-01
• Secondary ID: 2009-A00848-49
• Status: Terminated
• Phase: N/A
• First received: August 8, 2011
• Last updated: January 2, 2018
• Start date: June 15, 2012
• Est. completion date: June 28, 2016

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 119
• Est. completion date: June 28, 2016
• Est. primary completion date: June 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Death
• Death, Sudden
• Stress Disorders, Post-Traumatic

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Beaujon -APHP	Clichy
France	Assistance Publique - Hopitaux de Marseille	Marseille
France	CHU Lapeyronie	Montpellier Cedex 05
France	Hôpital Gui De Chauliac (CHU de Montpellier)	Montpellier cedex 5
France	Centre Hospitalier Universitaire de Nîmes	Nîmes cedex 09
France	Hôpital Kremlin Bicêtre - APHP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IES-R > 37: yes/no	Impact of Event Scale score greater than 37: yes/no	6 weeks
Secondary	IES-R	Impact of Event scale score (score varying from 0 (no risk of post traumatic stress) to 88 (highest risk of post traumatic stress)).	6 weeks
Secondary	HDAS score	Hospital Depression and Anxiety Score (varies from 0 to 21). A score >8 indicates clinically significant anxiety/depression.	6 weeks