JPRN-jRCT1062220035招募中未知
Hypothermia versus Normothermia: Comparing 30-day Neurological Outcomes after Out-of-Hospital Cardiac Arrest with Moderate Initial Illness Severity: Multicenter Randomized Controlled Trial
aito Hiromichi0 个研究点目标入组 380 人开始时间: 2022年6月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 380
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 79age old(—)
- 性别
- All
入选标准
- •1) Out-of-hospital cardiac arrest with medical pathogenesis (medical pathogenesis includes cases in which the cause of the cardiac arrest is presumed to be cardiac, other medical cause [eg, anaphylaxis, asthma, GI bleed], and in which there is no obvious cause of the cardiac arrest)
- •2) Age 18 years old or older but not older than 79 years
- •3) Sustained return of spontaneous circulation (ROSC defined as 20 minutes with signs of circulation without the need for chest compressions), unconscious (defined as Glasgow Coma Scale [GCS] score of 8 or less and GCS motor response score of 5 or less)
- •4) Eligible for intensive care without any restrictions or specific limitations
- •(No limitations in therapy and does not have a Do-Not-Attempt-Resuscitation order)
- •5) Randomization within 180 minutes after ROSC
- •6) Post-cardiac arrest syndrome of moderate severity (defined by revised post-cardiac arrest syndrome for therapeutic hypothermia (rCAST) score: rCAST of 5.5 to 15.5)
排除标准
- •1) Major hemodynamic instability
- •(Systolic blood pressure 80 mmHg or lower despite fluid loading/vasopressors or inotropic support)
- •2) Temperature on admission 32 degrees Celsius or lower or 40 degrees Celsius or higher
- •3) Supported by extracorporeal membrane oxygenation prior to ROSC
- •4) Pregnancy
- •5) Patients with acute intracranial bleeding, acute subarachnoid hemorrhage, acute cerebral infarction, acute aortic dissection, or end-stage cancer
- •6) Severe chronic obstructive pulmonary disease (COPD) with home oxygen therapy
- •7) Chronic kidney disease requiring dialysis
- •8) Pre-arrest Cerebral Performance Category 3 or 4 or Overall Performance Category 3 or 4
- •9) Known disease or condition that makes survival with the 40-hour intervention period unlikely
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