Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance
This study has been completed.
Sponsor:
Delafontaine Hospital
Information provided by:
Delafontaine Hospital
ClinicalTrials.gov Identifier:
NCT00615225
First received: February 4, 2008
Last updated: February 13, 2008
Last verified: February 2008
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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 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Christophe Adrie, Delafotaine Hospital |
| ClinicalTrials.gov Identifier: | NCT00615225 History of Changes |
| Other Study ID Numbers: | CCPPRB/114-02, Agence de Biomédecine 2005 |
| Study First Received: | February 4, 2008 |
| Last Updated: | February 13, 2008 |
| 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 |
Additional relevant MeSH terms:
|
Brain Death Death Brain Diseases Central Nervous System Diseases Nervous System Diseases Coma |
Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013