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临床试验/jRCT1060240086
jRCT1060240086尚未招募不适用

Hypothermia versus normothermia after extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest: A cluster randomized trial (SAVE-J NEUROTHERM trial)

未提供0 个研究点目标入组 468 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
468
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 75age old under(—)
性别
All

入选标准

  • Out-of-hospital cardiac arrest
  • Age of 18-75 years, known or as estimated
  • Initial cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia or pulseless electrical activity

排除标准

  • ECMO initiated after sustained return of spontaneous circulation (ROSC), patients with sustained ROSC before ECMO initiation
  • OHCA of presumed non-cardiac etiology
  • Time from emergency call or witnessed arrest to hospital arrival > 60 minutes
  • Time from hospital arrival to ECMO initiation > 60 minutes
  • Prehospital ECPR
  • Unavailability of the ECMO heat exchanger for temperature control
  • Glasgow Coma Scale (GCS) before temperature control >8
  • Core body temperature upon hospital arrival under 32 degrees Celsius
  • Surgical intervention before temperature control (e.g., surgical intervention for the primary disease or complications related to resuscitation/ECMO procedures)
  • Do Not Attempt Resuscitation (DNAR) order confirmed prior to temperature control
  • Limitations in intensive care before temperature control
  • Known cerebral performance category (CPC) of 3-4 before cardiac arrest
  • Known chronic obstructive pulmonary disease with home oxygen therapy
  • Known or as estimated pregnancy
  • Concomitant illness such as malignancy shortens life expectancy (180 day survival unlikely)
  • Consent not obtained or withdrawn by the participant or surrogate
  • Other reasons, physician decision not to enroll

结局指标

主要结局

-

Survival at hospital discharge

次要结局

  • Serious adverse events(during ICU)

研究者

发起方
未提供

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