Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance

February 13, 2008 updated by: Delafontaine Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any brain dead patients diagnosed in three different ICUs

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Delafontaine Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

February 14, 2008

Last Update Submitted That Met QC Criteria

February 13, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCPPRB/114-02
  • Agence de Biomédecine 2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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