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临床试验/NCT01500785
NCT01500785终止4 期

Intracoronary Administration of Levosimendan in Cardiac Surgery Patients

Tampere University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年6月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
50
试验地点
1
主要终点
change in cardiac output

研究概览

简要总结

Incomplete recovery from ischemia causes stunned myocardium. Ischemia may be due to coronary artery disease or aortic cross-clamping during surgery. Stunning leads to myocardial dysfunction. It has been suggested that the mechanism responsible for the contractile depression in stunned myocardium is a decreased sensitivity of the myofibrils to calcium. Levosimendan is a calcium sensitizer, which has been shown to improve the function of stunned myocardium without obvious impairment of diastolic function. Systemic vasodilation and need of vasoconstrictive medication is usually apparent after administration of levosimendan. Colucci et al have demonstrated that with intracoronary administration of milrinone, another inodilator, systemic vasodilation could be excluded. If this is true with levosimendan, it may be possible to improve left ventricular hypo/dyskinesia without afterload reduction by adding levosimendan into cardioplegia solution.

The investigators hypotize that levosimendan, delivered together with cardioplegia, can improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline. Secondary endpoints are a change in LV ejection fraction from baseline to 5 min after sternal closure and cTnT/CK-MB on the first postoperative morning.

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

入选标准

  • preoperative LVEF 40% or less
  • septal wall thickness more than 11mm
  • less than moderate aortic insufficiency
  • sinus rhythm before CPB

排除标准

  • oesophageal disease
  • known allergy to levosimendan or its metabolites or adjuvants.

研究组 & 干预措施

levosimendan

Active Comparator

干预措施: levosimendan (Drug)

placebo

Placebo Comparator

干预措施: Vitamin B 12 (Drug)

结局指标

主要结局

change in cardiac output

时间窗: from baseline to 15min after weaning from CPB

Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia).

次要结局

  • EF(from baseline to 5 min after sternal closure)
  • cTnT/CK-MB on the first postoperative morning.(from baseline to 1st post. op. morning)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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