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- •Consent not obtained or withdrawn by the participant or surrogate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
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