Efficacy and Safety of Target-directed Management of Cerebral Oxygenation in Patients Undergoing Extracorporeal Cardiopulmonary Resuscitation: A Multicenter, Pragmatic, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 654
- 试验地点
- 2
- 主要终点
- 30-day survival rate with favorable neurological status
研究概览
简要总结
Neurological injury remains an important cause of morbidity and mortality in patients with ECPR. At present, the results of three prospective randomized controlled studies on ECPR are inconsistent, and it is inconclusive whether ECPR can improve the neurological outcomes of patients with refractory cardiac arrest. Several study found that extracorporeal membrane oxygenation nonsurvivors can lead toacute brain injury.Further research with a systematic neurologic monitoring is necessary to define the timing of acute brain injury in patients with extracorporeal membrane oxygenation.Moreover, brain injury that occurs during extracorporeal membrane oxygenation therapy is not easy to detect in time because of the use of analgesics, sedatives, and muscle relaxants. Surprisingly, little attention has been paid to the role of cerebral perfusion and oxygenation. Moreover,the features of cerebrovascular pathophysiology and optimal management strategies are still vague.
Therefore multimodal neuromonitoring may be a valuable tool for detecting brain injury in patients with extracorporeal membrane oxygenation and providing early intervention guidance.
Multimodal neuromonitoring, integrating tools such as near-infrared spectroscopy (NIRS), transcranial Doppler, and continuous electroencephalography, may enable early detection of brain injury and guide targeted interventions.
Hypothesis: Multimodal neuromonitoring combined with a standard care management will increase the proportion of patients achieving survival with favorable neurological outcome (Cerebral Performance Category [CPC] 1-2) at 30 days compared with standard care without protocolized neuromonitoring.
Primary Objective: To test whether a multimodal neuromonitoring strategy improves 30-day survival with favorable neurological outcome (CPC 1-2) in adult patients with refractory cardiac arrest treated with ECPR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •Witnessed in-hospital or out-of-hospital cardiac arrest
- •Patients who did not achieve return of spontaneous circulation (ROSC) after 15 minutes of conventional cardiopulmonary resuscitation (CPR), or whose ROSC cannot be maintained, and who received ECPR
- •Time from cardiac arrest to initiation of CPR < 10 minutes
- •The cause of cardiac arrest is expected to be reversible (e.g., hypothermia, acute myocardial infarction/myocardial ischemia, malignant arrhythmia, pulmonary embolism, electrolyte abnormalities, hypoxia, anaphylactic shock, hemorrhage/hypovolemia, drug poisoning, electric shock, etc.)
排除标准
- •Aortic dissection
- •Participants with active gastrointestinal bleeding or other conditions with contraindications to anticoagulation
- •Severe trauma
- •Cerebral Performance Category (CPC) score > 2 before cardiac arrest, or acute cerebrovascular disease (e.g., suspected or confirmed acute stroke, subarachnoid hemorrhage, etc.)
- •Terminal diseases, such as malignant tumors, end-stage liver and kidney diseases, severe heart failure (NYHA class III or IV), severe COPD (GOLD class III or IV), etc.
- •Transfer time from cardiac arrest to extracorporeal membrane oxygenation (ECMO) > 90 minutes
- •Previous history of bilateral femoral artery bypass grafting or artificial vascular replacement, unsuitable for ECMO catheterization
结局指标
主要结局
30-day survival rate with favorable neurological status
时间窗: 30 days
Cerebral Performance Category (CPC) score will be performed to evaluate the neurological status. A CPC score of 1 or 2 indicates a favorable neurological status.
次要结局
- Survival with favorable neurological status at 3, 6 months(3 months, 6 months)
- Time to return of circulation(Within 1 year)
- Duration of mechanical ventilation(1 year)
- Length of stay at the ICU(1 year)
- Length of stay at the hospital(1 year)
- Duration of hypothermia(1 year)
- Difference in NSE, S100 B level between treatment groups(3 days)
研究者
Feng Xu
Professor
Qilu Hospital of Shandong University