Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance

Brain Death Clinical Trial

Official title:

Observational Study on the Systemic Inflammatory Response During Brain Death.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615225
• Other study ID #: CCPPRB/114-02
• Secondary ID: Agence de Bioméd
• Status: Completed
• Phase: N/A
• First received: February 4, 2008
• Last updated: February 13, 2008
• Start date: January 2000
• Est. completion date: December 2007

Study information

• Verified date: February 2008
• Source: Delafontaine Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age < 18years

Study Design

N/A

Related Conditions & MeSH terms

• Brain Death
• Death

Intervention

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

Locations

Country	Name	City	State
Belgium	Liege Hospital	Liege
France	Tenon Hospital	Paris
France	Delafontaine Hospital	Saint Denis

Sponsors (1)

Lead Sponsor	Collaborator
Delafontaine Hospital

Countries where clinical trial is conducted

Belgium,  France,