Comparison of Intravenous Levosimendan and Inhalational Milrinone in High Risk Cardiac Patients With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 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 this study is to examine and compare the effect of Levosimendan and Milrinone administered intravenously and via inhalation respectively in cardiac surgery patients with pulmonary hypertension and right ventricular dysfunction.
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, the intravenous administration of Levosimendan will be compared with the inhalational use of milrinone in patients with pulmonary hypertension undergoing cardiac surgery.
In this setting, 40 patients with PH caused by left sided heart disease, will be assigned into two groups:
GROUP A: Intravenous administration of Levosimendan in dosage 6mcg/kg after induction of anesthesia.
GROUP B: Inhalational administration of milrinone in dosage 50mcg/kg after induction of anesthesia.
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
Intravenous administration of Levosimendan at a dosage of 6 mcg/kg after induction of anesthesia
in this group, 6 mcg/kg of levosimendan will be administered intravenously after anesthesia induction, aiming at prevention of pulmonary hypertension post bypass
干预措施: levosimendan at a dose of 6 mcg/kg (Drug)
Inhalational administration of Milrinone at a dosage of 50 mcg/kg after induction of anesthesia
in this group, 50 mcg/kg of milrinone will be administered via inhalation after anesthesia induction, aiming at prevention of pulmonary hypertension post bypass
干预措施: milrinone at a dose of 50 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 vasodilator 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
change from baseline in mean arterial pressure (MAP)
时间窗: 20 minutes after vasodilator 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
change from baseline in systemic vascular resistance (SVR)
时间窗: 20 minutes after vasodilator 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
length of ICU stay
时间窗: postoperatively, an average period of 7-10 days
duration of patient stay in ICU in days
hospitalization time
时间窗: postoperatively, up to 20 days after the operation
duration of hospital stay after surgery in days
change from baseline in fractional area change
时间窗: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
transthoracic and transesophageal echocardiography will be used for echocardiographic measurements
change from baseline in pulmonary vascular resistance (PVR)
时间窗: 20 minutes after vasodilator 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
change from baseline in pulmonary capillary wedge pressure (PCWP)
时间窗: 20 minutes after vasodilator 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
change from baseline in cardiac output (CO)
时间窗: 20 minutes after vasodilator 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
change from baseline in tricuspid annular plane systolic excursion (TAPSE)
时间窗: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
transthoracic and transesophageal echocardiography will be used for echocardiographic measurements
次要结局
未报告次要终点
研究者
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital