We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01412502
Recruitment Status : Terminated (no recruitment)
First Posted : August 9, 2011
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Stress Disorders, Post-Traumatic Other: IES-R and HDAS scores

Study Design

Study Type : Observational
Actual Enrollment : 119 participants
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
Actual Study Start Date : June 15, 2012
Primary Completion Date : June 28, 2016
Study Completion Date : June 28, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. IES-R > 37: yes/no [ Time Frame: 6 weeks ]
    Impact of Event Scale score greater than 37: yes/no


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

  2. HDAS score [ Time Frame: 6 weeks ]
    Hospital Depression and Anxiety Score (varies from 0 to 21). A score >8 indicates clinically significant anxiety/depression.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412502


Locations
France
Hôpital Beaujon -APHP
Clichy, France
Assistance Publique - Hopitaux de Marseille
Marseille, France
CHU Lapeyronie
Montpellier Cedex 05, France, 34295
Hôpital Gui De Chauliac (CHU de Montpellier)
Montpellier cedex 5, France, 34295
Centre Hospitalier Universitaire de Nîmes
Nîmes cedex 09, France, 30029
Hôpital Kremlin Bicêtre - APHP
Paris, France
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

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 ( Other Identifier: RCB number )
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Death, Sudden
Brain Death
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations