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临床试验/NCT01318460
NCT01318460已完成4 期

Prophylactic Administration of Levosimendan in Patients With Impaired Left Ventricular Function Undergoing Coronary Surgery

AHEPA University Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年3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
入组人数
32
试验地点
1
主要终点
Left ventricular function

研究概览

简要总结

The present pilot study aims to investigate the effectiveness of the preoperative infusion of levosimendan in patients with impaired left ventricular function undergoing coronary artery bypass grafting.

详细描述

Myocardial revascularization in patients with impaired left ventricular function remains a serious problem in cardiac surgery. Despite the recent developments with the use of new surgical techniques (mini-extracorporeal circulation, off pump surgery) the perioperative morbidity and mortality are relatively high. Therapeutic solutions with the use of inotropic drugs, as adrenergic agonists and phosphodiesterase inhibitors, have offered important improvement to the hemodynamic status of these patients, but they have not considerably decreased mortality. These drugs owe their positive inotropic action to the increase of intracellular calcium and thereafter they improve the myocardial function.

Levosimendan (SIMDAX) is a new calcium sensitizer which increases the myocardial contractility without particular promotion of the intracellular calcium accumulation. Contemporary experimental and clinical data demonstrated the effectiveness of this drug in the reduction of surgical mortality to the patients with low left ventricular ejection fraction (LVEF) who undergo coronary artery bypass grafting (CABG).

This is an original prospective randomized controlled study focused on the preoperative use of this drug in patients with impaired left ventricular function which is associated with a high operative risk (i.e. EuroSCORE). Perioperative myocardial stunning is particularly evident in this cohort of patients. Prophylactic administration of levosimendan the day before the operation could be translated in improved myocardial performance intraoperatively and during the early postoperative period.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • coronary artery disease which warrants myocardial revascularization with coronary artery bypass grafting according to current guidelines
  • age < 79 years old
  • left ventricular ejection fraction <= 40%
  • informed patient's consent

排除标准

  • age < 18 years old
  • emergency surgery
  • medical history of acute myocardial infarction with ST elevation (STEMI) less than 14 days old
  • any severe comorbidity which increases the perioperative risk (i.e. neoplasia, rheumatoid arthritis, chronic obstructive pulmonary disease)
  • need for valvular replacement surgery
  • redo surgery
  • serum creatinine > 2 mg/dl
  • history of malignant cardiac arrhythmias

研究组 & 干预措施

Levosimendan

Active Comparator

Patients treated with prophylactic administration of levosimendan

干预措施: Levosimendan infusion (Drug)

Placebo group

Placebo Comparator

Patients managed with placebo administration

干预措施: Placebo infusion (Drug)

结局指标

主要结局

Left ventricular function

时间窗: Seventh postoperative day

Left ventricular function as assessed by transthoracic or transesophageal echocardiography on the seventh postoperative day

次要结局

  • Total ICU stay(1st-7th postoperative day)
  • Morbidity(1st-7th postoperative day)
  • Time on mechanical ventilation(1st-7th postoperative day)
  • Perioperative mortality(30 days postoperatively)
  • Inotropic support(1st-7th postoperative day)
  • Need for intraaortic balloon pump(1st-7th postoperative day)
  • Total length of hospital stay(1st-7th postoperative day)
  • Major adverse cardiovascular events(1st-7th postoperative day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyriakos Anastasiadis

Head of Cardiothoracic Department

AHEPA University Hospital

研究点 (1)

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