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Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance

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ClinicalTrials.gov Identifier: NCT00615225
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : February 14, 2008
Sponsor:
Information provided by:
Delafontaine Hospital

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
Brain Death Procedure: Muscle biopsy

Study Type : Observational
Official Title: Observational Study on the Systemic Inflammatory Response During Brain Death.
Study Start Date : January 2000
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort 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





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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any brain dead patients diagnosed in three different ICUs
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18years

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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): NCT00615225


Locations
Belgium
Liege Hospital
Liege, Belgium
France
Tenon Hospital
Paris, France, 75020
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

Responsible Party: Christophe Adrie, Delafotaine Hospital
ClinicalTrials.gov Identifier: NCT00615225     History of Changes
Other Study ID Numbers: CCPPRB/114-02
Agence de Biomédecine 2005
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: February 14, 2008
Last Verified: February 2008

Keywords provided by Delafontaine Hospital:
brain death
inflammation
endotoxin
transplantation
graft
apoptosis
Systemic inflammatory response
Apoptosis activation
Graft outcome

Additional relevant MeSH terms:
Death
Brain Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations