Levosimendan Administration in High Risk Cardiac Surgery Patients With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- change from baseline in mean pulmonary arterial pressure (MPAP)
研究概览
简要总结
The aim of the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function.
详细描述
Pulmonary hypertension (PH) is a pathophysiological disorder hemodynamically characterized by increased pulmonary vascular resistance and pressure. This can lead to right ventricle pressure overload and failure which is worsened by cardiopulmonary bypass (CPB) and extracorporeal circulation and is accompanied by high rates of morbidity and mortality in cardiac surgery patients. Pharmacological agents used to decrease pulmonary vascular resistance and right ventricle afterload are prostaglandins, iloprost, milrinone, nitric oxide (NO) and recently Levosimendan. These agents can be administered intravenously or via inhalation.
In this study, Levosimendan will be administered in patients with pulmonary hypertension undergoing cardiac surgery. The aim of the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function. The drug will be administered in different doses to define the dose at which Levosimendan administration reduces pulmonary vascular resistance and pressure without causing significant reduction of systemic vascular resistance and pressure. The anti-inflammatory effect of the perioperative use of Levosimendan in cardiac surgery will also be studied.
In this setting, 45 patients with PH caused by left sided heart disease, will be assigned into three groups:
GROUP A: Administration of Levosimendan at a dosage of 3mcg/kg after anesthesia induction.
GROUP B: Administration of Levosimendan at a dosage of 6mcg/kg after anesthesia induction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with pulmonary hypertension due to left ventricular dysfunction based on echocardiographic diagnosis preoperatively
- •elective cardiac surgery
排除标准
- •primary pulmonary hypertension
- •thromboembolic disease
- •chronic obstructive pulmonary disease
- •emergency surgery
- •redo surgery
- •inability to consent to the study
研究组 & 干预措施
levosimendan administration at a dose of 3 mcg/kg after anesthesia induction
levosimendan will be administered at a dose of 3 mcg/kg after anesthesia induction
干预措施: levosimendan at a dose of 3 mcg/kg (Drug)
levosimendan administration at a dose of 6 mcg/kg after anesthesia induction
levosimendan will be administered at a dose of 6 mcg/kg after anesthesia induction
干预措施: levosimendan at a dose of 6 mcg/kg (Drug)
levosimendan administration at a dose of 12 mcg/kg after anesthesia induction
levosimendan will be administered at a dose of 12 mcg/kg after anesthesia induction
干预措施: levosimendan at a dose of 12 mcg/kg (Drug)
结局指标
主要结局
change from baseline in mean pulmonary arterial pressure (MPAP)
时间窗: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
a Swan-Ganz catheter will be used for hemodynamic measurements
次要结局
- change from baseline in systemic vascular resistance (SVR)(20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission)
- change from baseline in pulmonary vascular resistance (PVR)(20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission)
- change from baseline in cardiac output (CO)(20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission)
- change from baseline in mean arterial pressure (MAP)(20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission)
- change from baseline in pulmonary capillary wedge pressure (PCWP)(20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission)
- change from baseline in tricuspid annular plane systolic excursion (TAPSE)(20 minutes after levosimendan administration, at the end of surgery, 2 hours after Intensive Care Unit (ICU) admission and 80 hours after levosimendan administration)
- change from baseline in fractional area change(20 minutes after levosimendan administration, at the end of surgery, 2 hours after Intensive Care Unit (ICU) admission and 80 hours after levosimendan administration)
研究者
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital