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

NCT01412502 | Terminated

• 2 other identifiers: PHRC-N/2009/CB-012009-A00848-49
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 6

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

Tissue Donors; Tissue and Organ Procurement; Brain death; Withdrawal of life support

Outcome Measures

Primary Outcomes (1)

• IES-R > 37: yes/no

  Impact of Event Scale score greater than 37: yes/no

  6 weeks

Secondary Outcomes (2)

• IES-R

  6 weeks

• HDAS score

  6 weeks

Study Arms (3)

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.

Other: IES-R and HDAS scores

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.

Other: IES-R and HDAS scores

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.

Other: IES-R and HDAS scores

Interventions

IES-R and HDAS scores OTHER

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

Brain death with organ donation; Limitation/cessation of active treatment; Sudden death

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (6)

Hôpital Beaujon -APHP

Clichy, France

Location

Assistance Publique - Hopitaux de Marseille

Marseille, France

Location

CHU Lapeyronie

Montpellier, 34295, France

Location

Hôpital Gui De Chauliac (CHU de Montpellier)

Montpellier, 34295, France

Location

Centre Hospitalier Universitaire de Nîmes

Nîmes, 30029, France

Location

Hôpital Kremlin Bicêtre - APHP

Paris, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Death

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Yves Lefrant, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

• Caroline Boutin, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 9, 2011
• Study Start: June 15, 2012
• Primary Completion: June 28, 2016
• Study Completion: June 28, 2016
• Last Updated: January 3, 2018

Record last verified: 2018-01

Locations

FR (6)