NCT00610350已完成4 期
Levosimendan Pre-Treatment in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-Blind, Single Center, Prospective, Randomized, Placebo-Controlled Trial
University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Length of ICU stay
研究概览
简要总结
The aim of this study is to investigate whether pharmacological pre-treatment with levosimendan reduces intensive care unit (ICU) length of stay in patients undergoing elective myocardial revascularization under cardiopulmonary bypass.
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
- •intention to perform first-time multi-vessel CABG
排除标准
- •unstable angina
- •valvular disease
- •diabetes mellitus treated with sulphonylurea drugs
- •renal failure
- •severe hepatic disease
- •severe chronic obstructive pulmonary disease
- •a history of prior CABG surgery
- •recent myocardial infarction (MI) within the previous month
研究组 & 干预措施
L
Experimental
干预措施: levosimendan (Drug)
P
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Length of ICU stay
时间窗: two weeks
次要结局
- Length of hospital stay(3 weeks)
- Tracheal intubation time(one week)
- Inotropic support over the first 7 days(one week)
研究者
研究点 (1)
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