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Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00615225
First Posted: February 14, 2008
Last Update Posted: February 14, 2008
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.
Information provided by:
Delafontaine Hospital
February 4, 2008
February 14, 2008
February 14, 2008
January 2000
November 2007   (Final data collection date for primary outcome measure)
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No Changes Posted
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Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance
Observational Study on the Systemic Inflammatory Response During Brain Death.
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.
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Observational
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Non-Probability Sample
Any brain dead patients diagnosed in three different ICUs
Brain Death
Procedure: Muscle biopsy
Muscle biopsies were taken through the operation site from the vastus lateralis thigh muscle at the beginning of surgery
  • Brain dead patients
    All patients meeting criteria for brain death
    Intervention: Procedure: Muscle biopsy
  • Healthy control
    Any healthy volunteers accepting to give some blood
  • Volunteers having hip surgery
    Patients undergoing hip surgery for degenerative non-inflammatory hip disease
    Intervention: Procedure: Muscle biopsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2007
November 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All brain dead patients whatever the cause (cardiac arrest, stroke, head trauma)

Exclusion Criteria:

  • Age < 18years
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   France
 
 
NCT00615225
CCPPRB/114-02
Agence de Biomédecine 2005
No
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Christophe Adrie, Delafotaine Hospital
Delafontaine Hospital
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Principal Investigator: Christophe Adrie, MD, PhD Delafontaine Hospital
Study Director: Jean Marc Cavaillon, ScD Pasteur Institute
Delafontaine Hospital
February 2008