Myocardial Protection With Esmolol in Patients With Hypertrophic Obstructive Cardiomyopathy Undergoing Surgery Under Cardiopulmonary Bypass
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Peak concentration of Troponin I
研究概览
简要总结
Perioperative blockage of beta-adrenoreceptors is widely used in cardiac and non-cardiac surgery to reduce the rate of cardiovascular complications. Several randomized-controlled studies and meta-analysis showed that esmolol reduces the incidence of myocardial ischemia and arrhythmias in cardiac surgery as well as enhances postoperative cardiac performance. No studies assessed the influence of esmolol in patients with hypertrophic obstructive cardiomyopathy undergoing cardiac surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Signed informed consent
- •Patient with hypertrophic obstructive cardiomyopathy undergoing surgery under cardiopulmonary bypass
排除标准
- •History of adverse effects on esmolol
- •Urgent/emergent surgery
- •Administration of esmolol in 30 days before randomization
- •Participation in other randomized trial during same hospitalization
研究组 & 干预措施
Esmolol
1 mg/kg (max. 100 mg) as a bolus before aortic cross-clamping and 2 mg/kg (max. 200 mg) in the cardioplegia solution
干预措施: Esmolol (Drug)
Placebo
Equivalent volume of saline as a bolus before aortic cross-clamping and in the cardioplegic solution
干预措施: Placebo (Drug)
结局指标
主要结局
Peak concentration of Troponin I
时间窗: From the randomization to the postoperative day 3 (POD 3)
次要结局
- The incidence of acute kidney injury(through study completion, an average of 4 weeks)
- Peak serum creatinine concentration(through study completion, an average of 4 weeks)
- The need for (yes/no) inotropic agents(through study completion, an average of 4 weeks)
- The need for (yes/no) defibrillation(through study completion, an average of 4 weeks)
- Left ventricular ejection fraction(through study completion, an average of 4 weeks)
- The incidence of new-onset moderate and severe arrhythmias of cardiac arrest(through study completion, an average of 4 weeks)
- Duration of mechanical ventilation(through study completion, an average of 4 weeks)
- Duration of ICU stay(through study completion, an average of 4 weeks)
- Duration of hospital stay(through study completion, an average of 4 weeks)
- 30-day all-cause mortality(through study completion, an average of 4 weeks)
- Presence of diastolic dysfunction(through study completion, an average of 4 weeks)
- The dosage of inotropic agents (inotropic score)(through study completion, an average of 4 weeks)