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临床试验/NCT00457431
NCT00457431终止不适用

Hypothermia After In-hospital Cardiac Arrest

University Hospital Schleswig-Holstein2 个研究点 分布在 1 个国家目标入组 249 人开始时间: 2007年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
249
试验地点
2
主要终点
all cause mortality at 6 months

研究概览

简要总结

ILCOR Recommendations "On the basis of the published evidence to date, the Advanced Life Support (ALS) Task Force of the International Liaison Committee on Resuscitation (ILCOR) made the following recommendations in October 2002: Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32°C to 34°C for 12 to 24 hours when the initial rhythm was ventricular fibrillation (VF).Such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest" (Circulation. 2003;108:118-121). This study ist to investigate the efficacy of mild therapeutic hypothermia on mortality and neurological outcome in patients after in-hospital cardiac arrest.

详细描述

This is a randomized controlled multicenter trial. Patients after in-hospital cardiac arrest are randomized either to standard therapy or to standard therapy in addition to mild therapeutic hypothermia. Mild therapeutic hypothermia is performed for 24 hours with a target temperature of 32-34°C. Inclusion criteria are: Adult patients which have been resuscitated after cardiac arrest in-hospital and who remain unconscious after restoration of spontanous circulation. Exclusion criteria are: severe cardiogenic shock, severe rhythm disorders, major surgery within the last 10 days, planned surgery within the next 24 hours afer resuscitation, active bleeding, suspicion od intracranial bleeding, severe infection, such as pneumonia or sepsis, a severe neurological deficit before cardiac arrest, an aquired immun deficency, pregnacy. The primary endpoint is mortality for all causes after six months. Secondary endpoints are neurological outcome after six months measured by the Glasgow-Pittsburgh Cerebral Performance scale, and in-hospital-mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • in-hospital cardiac arrest
  • restoration of spontanous circulation
  • unconsciousness
  • age over 18
  • initiation of mild therapeutic hypothermia is possible within 4h after resuscitation

排除标准

  • active bleeding
  • suspicion of intra cranial bleeding
  • severe infection
  • aquired immun deficency
  • severe rhythm disorders
  • suspicion of cerebral insult
  • known severe cognotive deficit before the index event
  • pregnancy
  • pre existing disease which makes 6 months survival unlikely

结局指标

主要结局

all cause mortality at 6 months

时间窗: 6 months

次要结局

  • in-hospital all cause mortality(time until discharge or death)
  • neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale(6 months)

研究者

发起方
University Hospital Schleswig-Holstein
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebastian Wolfrum

D. Sebastian Wolfrum

University Hospital Schleswig-Holstein

研究点 (2)

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