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临床试验/NCT01083069
NCT01083069Unknown不适用

Neurological Outcome After Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation

University of Leipzig1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Neurological outcome after 6 month after MIH, Quality of life-survey

研究概览

简要总结

Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the long term neurological outcome after mild hypothermia after restoration of spontaneous circulation.

详细描述

Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC).

研究设计

研究类型
Observational
观察模型
Case Control
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

  • survived cardiac arrest
  • voluntary consent

排除标准

  • no voluntary consent

结局指标

主要结局

Neurological outcome after 6 month after MIH, Quality of life-survey

时间窗: 6 Month

Neurological outcome after 6 month after MIH measured by questionnaire.

次要结局

  • Managing daily activities(6 Month)
  • Neurological Outcome in consideration of the practice of the treating instances.(6 month)
  • Neurological outcome depending of the beginning of MIH(6 month)
  • Surviving after hospitalization(6 Month)

研究者

发起方
University of Leipzig
申办方类型
Other

研究点 (1)

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