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临床试验/NCT02020759
NCT02020759已完成不适用

Cerebral Microemboli in Critically Ill Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年6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
Cerebral embolic load

研究概览

简要总结

Extracorporeal membrane oxygenation (ECMO) is progressively used in critically ill patients with cardiac or respiratory failure as a bridging option for potential organ recovery. However, ECMO survivors often suffer from poor neurocognitive outcome due to neurological complications such as microembolic (ME) strokes.

In venoarterial (va) ECMO circuits the pulmonary circulation, which usually serves as microembolic filter, may be bypassed and generated ME are prone to reach the brain in substantial amounts and potentially impair cerebral integrity. Although patient exposure to cerebral ME has been thoroughly investigated in cardiopulmonary bypass procedures, there is only limited research on cerebral ME in patients undergoing ECMO therapy.

The primary study goal of this study is to determine the load and nature of cerebral ME in critically ill patients under va-ECMO support. We also aim to compare the results to measurements in healthy subjects und intensive care unit (ICU) patients without extracorporeal support to get a better impression on the relevance of ME generation during ECMO support.

详细描述

The addition of ICU patients was made according to reviewer suggestions after an initial submission to a medical journal.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • use of any other extracorporeal device including venovenous (vv) ECMO
  • continuous renal replacement therapy
  • medical history of severe mitral or aortic stenosis
  • medical history of severe mitral or aortic regurgitation
  • medical history of carotid stenosis > 70 %
  • septicaemia
  • medical history of vascular dementia or Alzheimer's disease
  • inclusion in an other clinical study
  • gravidity
  • allergy against materials of one of the medical device used in the study

结局指标

主要结局

Cerebral embolic load

时间窗: 30 minutes

Cerebral embolic load (solid and gaseous) is measured in a 30 minutes-interval during ECMO usage

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

Dr. Gabor Erdoes

Dr Gabor Erdoes

Medical University of Vienna

研究点 (1)

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