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临床试验/NCT01102153
NCT01102153已完成不适用

NSE as an Outcome Predictor of Therapeutical Hypothermia After Survived Sudden Cardiac Death

University of Leipzig1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
1
主要终点
neuron specific enolase (NSE) as a parameter for cerebral damage

研究概览

简要总结

Sudden cardiac death remains one of the major leading causes of death. Therapeutic hypothermia is a validated standard procedure to avoid or minimize cognitive deficits after cardiac arrest. To assess the efficiency of different cooling methods and further improve these methods, the investigators collected blood samples to measure the neuron specific enolase (NSE) in patients treated with invasive cooling as compared to patients treated with non-invasive cooling.

详细描述

Consecutive patients with restoration of spontaneous circulation after resuscitation due to sudden cardiac death were randomized to either non-invasive or invasive cooling for at least 24 hours. NSE was collected at designated time points and compared between patients treated with invasive cooling and those treated with non-invasive cooling. Neurological outcome was assessed between groups at hospital discharge and 6 months after discharge.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ROSC after sudden cardiac death (SCA) due to VF/VT or PEA/Asystolia

排除标准

  • Non-cardiac sudden death
  • Pregnancy
  • Unstable circulation with high-dose inotropics
  • Life-expectancy reducing concomitant illness

结局指标

主要结局

neuron specific enolase (NSE) as a parameter for cerebral damage

时间窗: 72 hours

Blood samples were collected at predefined time-points within 72 hours to measure neuron specific enolase.

次要结局

  • time to overall survival(one year)
  • neurologic outcome(6 months)

研究者

发起方
University of Leipzig
申办方类型
Other

研究点 (1)

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