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临床试验/NCT01878305
NCT01878305已完成不适用

Frontal Electroencephalogram Variables Are Associated With Outcome and Stage of Hepatic Encephalopathy in Acute Liver Failure

University of Helsinki1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Number of participants recovering without the need for a liver transplant

研究概览

简要总结

Neuromonitoring of critically ill patients in the intensive care unit (ICU) is challenging. Clinical scoring systems produce insufficient information with deeply sedated patients, and disturbances of normal hemostasis limit the use of invasive intra-cranial pressure measurements. EEG based monitoring algorithms have been introduced into the operation theater and general anaesthesia, but these algorithms cannot be used in the intensive care setting without modifications. EEG is also susceptible to electrical disturbances, such as those created by patient movement.

The study is conducted in Finland, in the intensive care unit of the Surgical Hospital of Helsinki. The total number of patients in this study is 20, and it is a part of a larger neuromonitoring study with a total of 110 patients. The patients are divided into four subgroups, as follows: 1. patients admitted to ICU with acute liver failure, 2. patients admitted to the postoperative cardio-thoracic ICU after cardiac surgery with perioperative total heart arrest, 3. patients admitted to the ICU because of status epilepticus and finally 4. patients in critical condition, admitted to the ICU after any surgery. This study concentrates on the first group of patients with acute liver failure.

Clinical care of patients is not altered. When arriving into the ICU EEG-monitoring will added to routine monitoring. To evaluate the neurological status the following tests are performed: clinical test, blood tests and transcranial doppler ultrasound. The Entropy of EEG is measured along with the raw EEG signal.

The recruiting of study patients was begun in December 2005 and the final study patients were recruited in December 2011. GE Healthcare Finland supplies the entropy monitoring devices and pays the salary of the research nurses who collect the study data. Clinical investigators will not receive funding from any commercial company. All patients (or their next of kin) included have given their written informed consent for inclusion in the study.

The aim of this study is to find new factors and new non-invasive techniques, which correlate with the neurological state and outcome of patients suffering critical illness.

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

  • age 18 or over
  • acute liver failure, referred to the ICU of the Surgical Hospital

排除标准

  • 未提供

结局指标

主要结局

Number of participants recovering without the need for a liver transplant

时间窗: Participant will be followed for the duration of their intensive care stay, an expected average of two weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juhani Akseli Stewart

Juhani Akseli Stewart, MD

University of Helsinki

研究点 (1)

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