NCT01595737已完成4 期
Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年2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
- 30
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
This study aims to examine the efficacy of levosimendan in terms of reducing postoperative mortality and severe morbidity in patients undergoing non-emergent surgery for coronary revascularisation with or without ischaemic mitral regurgitation and who may or may not require repair or replacement of the mitral valve and have a LVEF < 35%.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female > 18 years and < 85 years.
- •LVEF ≤ 35%
- •Indication for elective surgery for coronary revascularisation, with or without mitral valve repair.
- •Freely choose to participate in trial and sign an informed consent
排除标准
- •The patient does not accept the protocol.
- •Allergy (hypersensitivity) to levosimendan, any of its components or to riboflavin.
- •Severe hypotension or severe tachycardia prior to entering study.
- •Significant mechanical obstruction affecting ventricular filling and/or emptying.
- •History of Torsades.
- •Requirement for inotropic or vasoactive drugs or any type of mechanical assistance for 48 hours prior to surgery.
- •Onset of angina or acute myocardial infarction within 48 hours prior to surgery, or cardiogenic shock.
- •Surgery needs that are different from those planned.
- •Chronic or severe kidney failure requiring haemodialysis or peritoneal dialysis or creatinine clearance values below 30ml/min or presence of nephrotic syndrome.
- •Liver failure with transaminases 4 times above the normal maximum value.
- •The patient must undergo a concurrently scheduled surgery, such as for a valve other than the mitral.
- •When a screening cannot be performed at least during the 24 hours before surgery.
- •Uncontrolled diabetes mellitus (blood glucose > 24mmol/l or 432mg/dl).
- •History of any disease over the last five years that may compromise the patient's life, other than their heart disease.
- •The patient is currently abusing alcohol or toxic substances.
- •Presence of any other medical or psychiatric condition that the researcher believes makes a candidate ineligible for the study.
- •Women with childbearing potential who are not using an effective contraception method.
- •Participation in the last 30 days in any other study with either experimental drugs or devices.
- •Body Mass Index (BMI) greater than
- •Administration of levosimendan in the last 30 days.
研究组 & 干预措施
Levosimendan
Experimental
干预措施: Levosimendan (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mortality
时间窗: 30 days
Rate of mortality
Morbidity
时间窗: 30 days
Rate of morbidity
次要结局
- Dose of inotropic drugs used(30 days)
- Dose of vasoactive drugs used(30 days)
研究者
研究点 (1)
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