Effect of Remote Ischemic Post-conditioning on Neurologic and Cardiac Recovery in Out-of-hospital Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- neuron specific enolase
研究概览
简要总结
Ischemia-reperfusion leads to mitochondrial injury, ion-pump injury, cell membrane damage, cytotoxic edema, and excessive oxygen free radical formation, and eventually destroys cells. Cardiac arrest is an example of global ischemia; after spontaneous circulation is restored, ischemia-reperfusion injury develops in cardiac arrest survivors.
Remote ischemic postconditioning (RIPoC) involves the application of brief, reversible episodes of ischemia and reperfusion to a vascular bed or tissue, rendering remote tissues and organs resistant to ischemia-reperfusion injury. Accordingly, RIPoC has been suggested as adjunctive therapy to mitigate ischemia-reperfusion injury. RIPoC applied by repeated brief inflation-deflation of a blood pressure cuff protects against myocardial injury, and has been proven effective in acute myocardial infarction.
This study aims to perform a randomized controlled trial to determine whether RIPoC has a neuroprotective effect and aids in myocardial recovery in out-of-hospital cardiac arrest patients after restoration of spontaneous circulation.
Neuron-specific enolase (NSE) at 48 hours after restoration of spontaneous circulation will be measured as a primary outcome.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (19 years and older)
- •comatose out-of-hospital cardiac arrest with sustained restoration of spontaneous circulation
- •Undergoing targeted temperature management
- •Time of enrollment ≤ 6hrs from restoration of spontaneous circulation
- •cardiac arrest from medical cause (cardiac or other medical cause)
排除标准
- •Pre-existing dementia, brain injury, or dependence on others (cerebral performance category scale greater than 3)
- •Traumatic etiology for cardiac arrest
- •Protected population (pregnant, prisoner)
- •in-hospital cardiac arrest
- •Known bleeding diathesis
- •suspected or confirmed acute intracranial hemorrhage
- •suspected or confirmed acute ischemic stroke
- •Known limitations in therapy and do-not-resuscitate order
- •known disease making 180-day survival unlikely
- •>6 hours from restoration of spontaneous circulation to randomization
- •cardiac arrest from asphyxia (hanging, foreign body airway obstruction), drowning, drug overdose, or electrocution
- •peripheral vascular disease (Deep vein thrombosis, arteriosclerosis obliterans)
- •systolic blood pressure < 80 mmHg in spite of fluid loading/vasopressor and/or inotropic medication
结局指标
主要结局
neuron specific enolase
时间窗: at 48 hour after restoration of spontaneous circulation
expressed in ng/ml
次要结局
- change over troponin-I(at 24 hour and 48 hour after restoration of spontaneous circulation)
- change over creatinin kinase-MB(at 24 hour and 48 hour after restoration of spontaneous circulation)
- neurologic outcome(an average of 3 weeks after restoration of spontaneous circulation)
研究者
ByungKook Lee
Associate professor
Chonnam National University Hospital