跳至主要内容
临床试验/NCT00918970
NCT00918970终止不适用

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

Centre Hospitalier Universitaire de Saint Etienne3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
3
主要终点
the delay between the falling down of autonomic nervous system activity and the confirmation of the brain death using cerebral angiography

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • severe cerebral lesions
  • admitted in intensive care units

排除标准

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

结局指标

主要结局

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

时间窗: At confirmation of the brain death

次要结局

  • the number of patients and the number of organs removed(At the end of the study)

研究者

研究点 (3)

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