Time-differentiated Treatment With Mild Therapeutic Hypothermia Following Cardiac Arrest, a Multi Center Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 18
- 主要终点
- CPC
研究概览
简要总结
The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours therapeutic hypothermia.
详细描述
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death. However, in 2002 it was in two clinical trials demonstrated that mild therapeutic hypothermia in comatose OOH-CA victims yields a better cerebral outcome measured by Cerebral Performance Category Score (CPC) after 6 month. The optimal mild hypothermia treatment time is however not known. The two trials from 2002 apply the treatment for 12 and 24 hours respectively. In newborns with cerebral hypoxic damage the standard treatment time is 72 hours. It is therefore relevant to investigate the influence of the treatment time on the cerebral outcome in OOH-CA victims. In the present study cerebral outcome after mild therapeutic hypothermia (target temperature 33 degrees centigrade) in OOH-CA patients for 24 is compared to outcome after 48 hours of mild hypothermia. The main outcome parameter is mortality and CPC score measured 6 month after the treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out of hospital cardiac arrest of suspected cardiac origin
- •Return of spontaneous circulation (ROSC)
- •Glasgow Coma Score < 8
- •Estimated time interval from cardiac arrest to ROSC ≤ 60 min
排除标准
- •OOH-CA of suspected origin other than cardiac
- •In hospital Cardiac arrest
- •Terminal disease
- •Coagulation disorders
- •Unwitnessed asystolia
- •Time from cardiac arrest to start of hypothermia treatment > 240 min
- •Persistent cardiogenic shock (Systolic blood pressure < 80 mmHg despite inotropic treatment and aortic balloon pump).
- •CPC 3-4 before cardiac arrest
- •Acute intra cerebral bleeding
- •Acute stroke
- •Acute coronary artery bypass grafting
结局指标
主要结局
CPC
时间窗: 6 month
CPC = Cerebral Performance Category Score. The primary outcome of the study is analyzed as the proportion of patients with good neurological outcome in the two groups, (CPC 1-2) at 6 months after CA.
次要结局
- Adverse events(10 days)
- CPC at discharge(3 month)
- Mortality(6 month)