Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance

Sponsor
Delafontaine Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00615225
Collaborator
(none)
3
95

Study Details

Study Description

Brief Summary

We hypothesized that brain death is associated with an early systemic inflammatory response, possibly combined with activation of apoptotic cell death, two events that may contribute to induce rapid organ dysfunction. In this study of brain-dead donors and controls, we assayed plasma cytokines and soluble factors, investigated plasma endotoxin levels as a triggering factor for inflammation, measured ex vivo cytokine production by blood leukocytes to determine whether immunosuppression occurred after brain death, and examined skeletal muscle biopsies to look for evidence of inflammation and increased apoptosis in peripheral tissue.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Muscle biopsy

Study Design

Study Type:
Observational
Official Title:
Observational Study on the Systemic Inflammatory Response During Brain Death.
Study Start Date :
Jan 1, 2000
Actual Primary Completion Date :
Nov 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Brain dead patients

All patients meeting criteria for brain death

Procedure: Muscle biopsy
Muscle biopsies were taken through the operation site from the vastus lateralis thigh muscle at the beginning of surgery

Healthy control

Any healthy volunteers accepting to give some blood

Volunteers having hip surgery

Patients undergoing hip surgery for degenerative non-inflammatory hip disease

Procedure: Muscle biopsy
Muscle biopsies were taken through the operation site from the vastus lateralis thigh muscle at the beginning of surgery

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All brain dead patients whatever the cause (cardiac arrest, stroke, head trauma)
    Exclusion Criteria:
    • Age < 18years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Liege Hospital Liege Belgium
    2 Tenon Hospital Paris France 75020
    3 Delafontaine Hospital Saint Denis France 93205

    Sponsors and Collaborators

    • Delafontaine Hospital

    Investigators

    • Principal Investigator: Christophe Adrie, MD, PhD, Delafontaine Hospital
    • Study Director: Jean Marc Cavaillon, ScD, Pasteur Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00615225
    Other Study ID Numbers:
    • CCPPRB/114-02
    • Agence de Biomédecine 2005
    First Posted:
    Feb 14, 2008
    Last Update Posted:
    Feb 14, 2008
    Last Verified:
    Feb 1, 2008

    Study Results

    No Results Posted as of Feb 14, 2008