Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance

NCT ID: NCT00615225

Last Updated: 2008-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Death

Study Groups

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Brain dead patients

All patients meeting criteria for brain death

Muscle biopsy

Intervention Type PROCEDURE

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

No interventions assigned to this group

Volunteers having hip surgery

Patients undergoing hip surgery for degenerative non-inflammatory hip disease

Muscle biopsy

Intervention Type PROCEDURE

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

Interventions

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Muscle biopsy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age \< 18years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Delafontaine Hospital

OTHER

Sponsor Role lead

Responsible Party

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Delafotaine Hospital

Principal Investigators

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Christophe Adrie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Delafontaine Hospital

Jean Marc Cavaillon, ScD

Role: STUDY_DIRECTOR

Pasteur Institute

Locations

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Liege Hospital

Liège, , Belgium

Site Status

Tenon Hospital

Paris, , France

Site Status

Delafontaine Hospital

Saint-Denis, , France

Site Status

Countries

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Belgium France

Other Identifiers

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Agence de Biomédecine 2005

Identifier Type: -

Identifier Source: secondary_id

CCPPRB/114-02

Identifier Type: -

Identifier Source: org_study_id

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