Clinical trial NCT00918970: Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death
Official title: Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death: the MEANS Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebral Hematoma, Traumatic
Intracerebral Hemorrhage, Traumatic
Traumatic Brain Hemorrhage
Traumatic Brain Injury
Keywords: autonomous nervous system
brain death
organs transplantation
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2009-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects with severe cerebral lesions admitted in intensive care units

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.

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

Primary outcomes:
measure: the delay between the falling down of autonomic nervous system activity and the confirmation of the brain death using cerebral angiography
timeFrame: At confirmation of the brain death
Secondary outcomes:
measure: the number of patients and the number of organs removed
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
city: Roanne
country: France
facility: CH Roanne
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: David CHARIER, MD
role: PRINCIPAL_INVESTIGATOR
References: