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

Terminated

• Conditions: Cerebral Hematoma, Traumatic; Intracerebral Hemorrhage, Traumatic; Traumatic Brain Hemorrhage; Traumatic Brain Injury

• Registration Number: NCT00918970
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study Start: 2008-08
• Status Verified: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-11
• Last Update Submitted: 2009-06-12
• Last Update Posted: 2009-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the delay between the falling down of autonomic nervous system activity and the confirmation of the brain death using cerebral angiography	At confirmation of the brain death

Secondary Outcome Measures

Name	Time	Method
the number of patients and the number of organs removed	At the end of the study

Trial Locations

Locations (3)

CHU de Dijon; 🇫🇷 Dijon, France

CH Roanne; 🇫🇷 Roanne, France

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France