The Effects of Levosimendan on Renal Function in Patients With Low Ejection Fraction Undergoing Mitral Valve Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery.
研究概览
简要总结
The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery will be investigated in a prospective, double-blinded, randomized clinical trial using serum creatinine (sCr)milligram in deciliter (mg/dL) values, calculated estimated glomerular filtration(eGFR)(ml/min/1.73 m2) rates and perioperative clinical follow-up parameters.
详细描述
Introduction:
The coronary and peripheral vasodilatory properties of levosimendan has recently been investigated in patients with heart failure. It is considered as a promising alternative to conventional inotropic agents for patients with low LVEF. However, the effects of levosimendan on renal functions in patients undergoing open heart surgeries with CPB are not well studied in randomized clinical trials.
The primary goal of our study was to investigate the effects of levosimendan on 1- renal function by evaluation of serum creatinine (mg/dL) values and calculated estimated glomerular filtration(eGFR)(ml/min/1.73 m2) rates.
Our secondary goal was to determine clinical outcomes including;
1-need for renal replacement therapy (RRT) in patients with low ejection fraction undergoing mitral valve repair or replacement surgery with cardiopulmonary bypass (CPB).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of mitral valve insufficiency with or without coronary artery disease and a LVEF of ≤ 45 %.
- •Exclusion criteria:
- •unstable angina,
- •diabetes mellitus treated with insulin, clinical findings of acute or chronic renal failure (sCr > 1.5 mg dL-1),
- •severe hepatic disease (alanine aminotransferase or aspartate aminotransferase > 100 U litre L-1),
- •severe chronic obstructive pulmonary disease (forced expired volume in 1 s < 50 % of predicted or < 2.0 litre),
- •a history of prior CABG surgery or myocardial infarction (MI) within the previous month,
- •emergent operations,
- •patients on inotropic support before operation,
- •aortic valvular disease, and
- •infective endocarditis.
排除标准
- 未提供
研究组 & 干预措施
Levosimendan, inotropic agent
In the levosimendan group, levosimendan will be used in addition to standard inotropic therapy (one or more agent including; dopamine, dobutamine, noradrenaline, adrenaline)for 24 hours.Levosimendan dosage; a loading dose of levosimendan (6 μg kg-1) will be administered after removal of the aortic cross-clamp, followed by an infusion of levosimendan at a dose of 0.1 μg kg-1 min-1.
干预措施: Levosimendan (Drug)
Control
In the control group, only standard inotropic therapy (one or more agent including; dopamine, dobutamine, noradrenaline, adrenaline)will be administered
干预措施: Dobutamine (Drug)
结局指标
主要结局
The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery.
时间窗: Between the time period of July 1, 2009 to January 30, 2013 participants will be followed for the duration of hospital stay, an expected average of 10 days.
The effects of levosimendan on postoperative renal function measured by serum creatinine (sCr) levels and estimated glomerular filtration rate (eGFR).
次要结局
- The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery.(Between the time period of July 1, 2009 to January 30, 2013 participants will be followed for the duration of hospital stay, an expected average of 10 days.)
研究者
Ayse Baysal
MD
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital