Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance - Full Text View

Sponsored by:	Delafontaine Hospital
Information provided by:	Delafontaine Hospital
ClinicalTrials.gov Identifier:	NCT00615225

Purpose

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	Intervention
Brain Death	Procedure: Muscle biopsy

Study Type:	Observational
Official Title:	Observational Study on the Systemic Inflammatory Response During Brain Death.

Further study details as provided by Delafontaine Hospital:

Study Start Date:	January 2000
Study Completion Date:	December 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615225

Locations

Belgium
Liege Hospital
Liege, Belgium
France
Delafontaine Hospital
Saint Denis, France, 93205
Tenon Hospital
Paris, France, 75020

Sponsors and Collaborators

Delafontaine Hospital

Investigators

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

More Information

No publications provided

Responsible Party:	Delafotaine Hospital ( Christophe Adrie )
Study ID Numbers:	CCPPRB/114-02, Agence de Biomédecine 2005
Study First Received:	February 4, 2008
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00615225 History of Changes
Health Authority:	France: Institutional Ethical Committee

Keywords provided by Delafontaine Hospital:

brain death
inflammation
endotoxin
transplantation
graft

apoptosis
Systemic inflammatory response
Apoptosis activation
Graft outcome

Study placed in the following topic categories:

Coma
Unconsciousness
Death
Brain Death
Consciousness Disorders

Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases
Neurobehavioral Manifestations
Inflammation

Additional relevant MeSH terms:

Coma
Unconsciousness
Death
Pathologic Processes
Brain Death
Consciousness Disorders

Nervous System Diseases
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on July 06, 2009