Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death

NCT ID: NCT00918970

Last Updated: 2009-06-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-06-30

Brief Summary

Context: A major lack of organ donors is a serious public health problem. It determines a prolonged delay before a transplant can be performed and thus a significant number of deaths of patients waiting for transplantation. The aim of this project is to reduce the delay of the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit.

The diagnosis of brain death is strictly defined by the law and relies either on two consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack of cerebral circulation during a brain angiography performed after suspecting brain death on the clinical exam. However, in usual practice, it is difficult to have all the needed clinical arguments, and their interpretation can be difficult in the pathological context. This may participate in the delay and the lack of patients potentially donors.

Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous ECG recording. The investigators could find that a decrease in autonomic nervous system activity, as measured through the ECG, was correlated to the transition to brain death assessed by cerebral angiography. The loss of cardiac variability was always observed between two cerebral angiographies, one before and the second after brain death. This study allowed the investigators to calculate the threshold values of sympathetic and parasympathetic activities to confirm brain death.

Detailed Description

Aim: The aim of this second study is to validate prospectively the interest of the analysis in real-time of autonomic nervous system activity to detect brain death.

Benefits expected: Increase the number of organ donors and the number of organs removal available for transplantation.

Conditions

Cerebral Hematoma, Traumatic; Intracerebral Hemorrhage, Traumatic; Traumatic Brain Hemorrhage; Traumatic Brain Injury

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

SNA group

This group will have a real-time analysis of autonomic nervous system activity during its intensive care hospitalisation

No interventions assigned to this group

Clinical group

This group will have a conventional clinical analysis during its intensive care hospitalisation

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• severe cerebral lesions
• admitted in intensive care units

Exclusion Criteria

• neoplastic pathology
• prior myocardiac infarction
• hearth failure
• atrial fibrillation
• insulin-treated diabetes mellitus
• cardiac pacemaker

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

CHU de SAINT-ETIENNE

Principal Investigators

David CHARIER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Dijon

Dijon, , France

CH Roanne

Roanne, , France

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

CNIL 908.476

Identifier Type: -

Identifier Source: secondary_id

0708045

Identifier Type: -

Identifier Source: org_study_id