Comparative Study Between Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension Undergoing Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- mean arterial pressure
研究概览
简要总结
The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery
详细描述
Milrinone is widely used in cardiac surgery as an inotrope and pulmonary vasodilator agent But , intravenous milrinone has been associated with systemic hypotension and increased requirement for vasoactive drugs
The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo mitral valve surgery by cardiopulmonary bypass with estimated mean pulmonary artery pressure =>55 estimated by using preoperative Doppler echocardiography
排除标准
- •Patients were excluded if they had surgery without CPB, preoperative hemodynamic instability (defined as acute requirement for vasoactive support or mechanical device),Patients with severe LV dysfunction (LV ejection fraction of less than 30% congenital heart disease, a contraindication to transesophageal echocardiography (TEE), emergency surgery or re-do surgeries severe renal or hepatic disease
- •, coagulopathy, and thromboembolic disease treated with anticoagulants
研究组 & 干预措施
Group IH(inhaled milrinone)
After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered
干预措施: Milrinone inhalation (Drug)
Group Iv(Intravenous milrinone)
After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered
干预措施: Milrinone infusion (Drug)
结局指标
主要结局
mean arterial pressure
时间窗: change in mean arterial pressure is recorded 10 minutes after milrinone administration after induction (T1), at the end of nebulization (T2), before cardiopulmonary bypass (T3) and after cardiopulmonary bypass(T4)
The effect of inhaled milrinone on mean arterial pressure is compared with the effect of intravenous milrinone
次要结局
- pulmonary vascular resistance(change in pulmonary vascular resistance 10 minutes after milrinone administration)
- mean pulmonary arterial pressure(change in mean pulmonary arterial pressure 10 minutes after milrinone administration)
- systemic vascular resistance(change in systemic vascular resistance 10 minutes after milrinone administration)
研究者
Heba Mohamed EL -Asser,MD
principal investigator
Zagazig University