ACTRN12611000477921已完成未知
A multi-centre randomised, parallel group, assessor-blinded clinical trial to compare all-cause mortality between a target temperature management of 33 degrees Celsius versus a target temperature management of 36 degrees Celsius after out-of-hospital cardiac arrest
Helsingborg Hospital0 个研究点目标入组 850 人开始时间: 2011年5月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 850
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Age greater than or equal to 18 years
- •2. OHCA of presumed cardiac cause
- •3. Sustained ROSC*
- •4. Unconsciousness (GCS <8) (patients not able to obey verbal commands) after sustained ROSC
- •* Sustained ROSC: Sustained ROSC is when chest compressions have been not required for 20 consecutive minutes and signs of circulation persist
排除标准
- •1. Conscious patients (obeying verbal commands)
- •2. Pregnancy
- •3. In-hospital cardiac arrest (IHCA)
- •4. OHCA of presumed non-cardiac cause, e.g. after trauma or dissection/rupture of major artery OR Cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging)
- •5. Known bleeding diathesis (medically induced coagulopathy e.g. warfarin, clopidogrel, does not exclude the patient)
- •6. Suspected or confirmed acute intracranial bleeding
- •7. Suspected or confirmed acute stroke
- •8. Unwitnessed asystole
- •9. A limitation of therapy order has been documented restricting implementation of the study protocol or the treating clinician deems aggressive care unsuitable
- •10. Known underlying disease making 180 day survival unlikely
- •11. Known pre-arrest CPC 3 or 4
- •12. >4 hours (240 minutes) from ROSC to screening
- •13. Systolic blood pressure <80 mmHg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump#
- •14. Temperature on admission <30 degrees Celsius
研究者
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