Pharmacokinetics and Pharmacodynamics of Levosimendan During Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- pharmacokinetics
研究概览
简要总结
The purpose of this study protocol is to evaluate the blood concentrations of levosimendan when administered at different doses clinically employed during cardiopulmonary bypass or cardiac manipulation during off pump surgery in patients who require the drug for inotropic support (improved heart function) and the associated hemodynamic variables (vital signs). Levosimendan is one of the first agents in a new class of drugs used to treat heart failure and works via a unique mechanism called calcium sensitization, that makes the heart beat more efficiently. Levosimendan also has unique effects on the blood vessels, as well as causing relaxation, an important therapeutic approach of heart failure therapy.
详细描述
This is a non-randomized trial, and the patients will be assigned to one of three dose groups following cardiopulmonary bypass or prior to manipulation of the heart in the off pump group. A total of 30 patients will be enrolled into this study, 20 off-pump and 10 subjects on pump. Levosimendan is approved in Europe for the treatment of decompensated heart failure. It improved cardiac function without increasing energy demands. The subject's enrollment ends at Day 7 or day of discharge, whichever comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 21 years of age
- •Less than 80 years of age
- •ASA Class III-IV
- •Scheduled for elective cardiac surgery
- •Signed informed consent
- •History of heart failure, and/or left ventricular ejection fraction <50%
排除标准
- •Emergency surgery
- •Withdrawal of consent
- •Uncontrollable ventricular arrhythmias
- •Obstructive cardiomyopathy
- •Confirmed pregnancy test for women of child-bearing potential
结局指标
主要结局
pharmacokinetics
时间窗: day of surgery
次要结局
- hemodynamics(day of surgery)