NCT00959569已完成4 期
Esmolol in Cardiac Surgery. A Randomized Controlled Trial With Clinical
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay.
研究概览
简要总结
This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •end diastolic diameter >60 mm and/or an ejection fraction <50%
- •written informed consent
- •age >18 years
排除标准
- •previous unusual response to esmolol
- •inclusion in other randomized studies
- •esmolol administration in the previous 30 days
- •emergency operation
研究组 & 干预措施
esmolol
Experimental
the study group will receive esmolol (1-3 mg/kg)
干预措施: Esmolol (Drug)
normosaline
Placebo Comparator
normosaline (same ml of the study drug)
干预措施: Placebo (Drug)
结局指标
主要结局
Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay.
时间窗: Hospital stay (approximately 2 weeks)
次要结局
- Number of patients with ventricular fibrillation after cardiopulmonary bypass(30 days and 1 year)
- Number of patients with low cardiac output syndrome(30 days and 1 year)
- peak postoperative cardiac troponin level(30 days and 1 year)
- Number of patients requiring post-operative inotropic support(30 days and 1 year)
研究者
Giovanni Landoni
MD
Università Vita-Salute San Raffaele
研究点 (1)
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