A Multicenter, Single-Blind Randomized Controlled Trial of TTM(Target Temperature Management) in Adults With ECPR(Extracorporeal Cardiopulmonary Resuscitation)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- 30-day survival outcomes
研究概览
简要总结
Investigators hypothesize that there is a difference in the 30-day survival rate and good neurological outcome rate between two groups of cardiac arrest patients undergoing ECPR, one group receiving hypothermia and the other group receiving normothermia. Among the patients undergoing extracorporeal cardiopulmonary resuscitation, after screening with inclusion criteria as well as exclusion criteria, informed consent for the experiment was signed and randomly assigned into 2 groups. One group underwent extracorporeal cardiopulmonary resuscitation combined with hypothermia (34°C) and the other group underwent extracorporeal cardiopulmonary resuscitation combined with normothermia (36.5-37.5℃). Information related to the prognosis of the participants in both groups was obtained, evaluated statistically, and final conclusions were drawn.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 and ≤60 years;
- •Patients with in-hospital and out-of-hospital cardiac arrest of any initial rhythm;
- •Patients who have received cardiopulmonary resuscitation for >10 minutes without achieving return of spontaneous circulation;
- •Patients with a reversible cause of cardiac arrest (acute myocardial infarction, pulmonary embolism, all initial defibrillatable rhythm, cardiomyopathy);
排除标准
- •cardiac arrest due to trauma;
- •pregnant and lactating women;
- •unwitnessed cardiac arrest;
- •out-of-hospital cardiac arrest not receiving CPR within 5 minutes;
- •> 60 minutes from the onset of cardiac arrest to the initiation of extracorporeal cardiopulmonary resuscitation;
- •achievement of return of spontaneous circulation before the start of external cardiopulmonary resuscitation;
- •intracranial hemorrhage or suspected intracranial hemorrhage;
- •pre-existing neurologic impairment (CPC ≥ 3) prior to the onset of cardiac arrest;
- •those with end-stage heart failure;
- •those with new-onset cerebral hemorrhage or cerebral infarction;
- •other vascular conditions such as severe plaque in bilateral femoral arteries that cause difficulty in tube placement;
- •patients with combined malignant tumors;
- •other serious diseases with a life expectancy of <1 year;
- •refusal to perform extracorporeal cardiopulmonary resuscitation and/or target temperature administrators.
- •Temperature <30°C.
结局指标
主要结局
30-day survival outcomes
时间窗: 30 days after randomization
All-cause survival rate of patients on day 30 after randomization.
30-day neurologic function outcomes
时间窗: 30 days after randomization
Rate of patients with good neurological outcome at day 30 of randomization.Good neurological outcome is defined as a cerebral performance category(CPC) score of 1 or 2.
次要结局
- prolong follow-up survival outcome(90 days and 6 months after randomization)
- prolong follow-up neurologic outcome(30 days, 3 months, and 6 months after randomization)
- Incidence of any bleeding, infection, arrhythmia, acute kidney injury and seizure [Safety and Tolerability](30 days after randomization)
研究者
Qingbian MA, MD
Director of the Emergency Department, Peking University Third Hospital
Peking University Third Hospital