Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance

This study has been completed.
Sponsor:
Information provided by:
Delafontaine Hospital
ClinicalTrials.gov Identifier:
NCT00615225
First received: February 4, 2008
Last updated: February 13, 2008
Last verified: February 2008

February 4, 2008
February 13, 2008
January 2000
November 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00615225 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational
Not Provided
Not Provided
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France,   Belgium
 
NCT00615225
CCPPRB/114-02, Agence de Biomédecine 2005
No
Christophe Adrie, Delafotaine Hospital
Delafontaine Hospital
Not Provided
Principal Investigator: Christophe Adrie, MD, PhD Delafontaine Hospital
Study Director: Jean Marc Cavaillon, ScD Pasteur Institute
Delafontaine Hospital
February 2008

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