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

NCT00918970 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2009-06-15

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • David CHARIER, MD · CHU de Saint-Etienne

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00918970 on ClinicalTrials.gov