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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01412502
First received: August 8, 2011
Last updated: October 2, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Stress Disorders, Post-Traumatic
Other: IES-R and HDAS scores

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Post Traumatic Stress Among the Nearest Relatives of Brain-dead, Withdrawal of Life Support, and Sudden Death Patients

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • IES-R > 37: yes/no [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Impact of Event Scale score greater than 37: yes/no


Secondary Outcome Measures:
  • IES-R [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Impact of Event scale score (score varying from 0 (no risk of post traumatic stress) to 88 (highest risk of post traumatic stress)).

  • HDAS score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Hospital Depression and Anxiety Score (varies from 0 to 21). A score >8 indicates clinically significant anxiety/depression.


Estimated Enrollment: 294
Study Start Date: June 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.
Other: 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.
Other: IES-R and HDAS scores
The Impact of Event Scale and Hospital Depression and Anxiety Score questionnaires are administered to participants.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412502

Contacts
Contact: Jean Yves Lefrant, MD PhD +33.(0)4.66.68.30.50 jean.yves.lefrant@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
Hôpital Beaujon -APHP Recruiting
Clichy, France
Sub-Investigator: Pierre Trouiller, MD         
Sub-Investigator: Claire Bonneville, MD         
Assistance Publique - Hopitaux de Marseille Recruiting
Marseille, France
Sub-Investigator: Marc Léone, MD PhD         
CHU Lapeyronie Recruiting
Montpellier Cedex 05, France, 34295
Sub-Investigator: Amaru Priscilla, MD         
Hôpital Gui De Chauliac (CHU de Montpellier) Recruiting
Montpellier cedex 5, France, 34295
Sub-Investigator: Florence Vachiéry-Lahaye, MD         
Centre Hospitalier Universitaire de Nîmes Recruiting
Nîmes cedex 09, France, 30029
Sub-Investigator: Jean Yves Lefrant, MD PhD         
Principal Investigator: Caroline Boutin, MD         
Sub-Investigator: Laurent Muller, MD         
Hôpital Kremlin Bicêtre - APHP Recruiting
Paris, France
Sub-Investigator: Jacques Duranteau, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Jean Yves Lefrant, MD PhD Centre Hospitalier Universitaire de Nîmes
Principal Investigator: Caroline Boutin, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01412502     History of Changes
Other Study ID Numbers: PHRC-N/2009/CB-01, 2009-A00848-49
Study First Received: August 8, 2011
Last Updated: October 2, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Tissue Donors
Tissue and Organ Procurement
Brain death
Withdrawal of life support

Additional relevant MeSH terms:
Death, Sudden
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Death
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014