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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 November 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: November 4, 2014
Last verified: November 2014

August 8, 2011
November 4, 2014
June 2012
November 2015   (final data collection date for primary outcome measure)
IES-R > 37: yes/no [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Impact of Event Scale score greater than 37: yes/no
Same as current
Complete list of historical versions of study NCT01412502 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Post Traumatic Stress Among Relatives of Brain-dead, Withdrawal of Life Support, and Sudden Death Patients
Evaluation of Post Traumatic Stress Among the Nearest Relatives of Brain-dead, Withdrawal of Life Support, and Sudden Death Patients

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Stress Disorders, Post-Traumatic
Other: IES-R and HDAS scores
The Impact of Event Scale and Hospital Depression and Anxiety Score questionnaires are administered to participants.
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Other: IES-R and HDAS scores
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
294
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
France
 
NCT01412502
PHRC-N/2009/CB-01, 2009-A00848-49
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Study Director: Jean Yves Lefrant, MD PhD Centre Hospitalier Universitaire de Nîmes
Principal Investigator: Caroline Boutin, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP