2- Inhaled Milrinone Prevents the Increase in Pulmonary Artery Pressure After CPB
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass
研究概览
简要总结
Pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac surgery with cardiopulmonary bypass (ECC). Milrinone used in inhalation, shows evidence of being a pulmonary vasodilator able to possibly contribute to the reduction of pressure on the pulmonary artery.
详细描述
This controlled, randomized, double-blind study will aim at confirming the efficiency as well as the security of Milrinone, used in inhalation, to diminish the degree of pulmonary hypertension before the cardiopulmonary bypass (ECC) circulation. In addition, the pharmacokinetic and echo graphic repercussions of administering the medication will be analysed. At the present time, there is no data on the pharmacokinetics of the medication when it's administered through inhalation. For this reason, we would like to study the serous rate of the medication in the minutes following its administration through inhalation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled for elective valvular or complex (2 or more valves or
- •valve and revascularization) cardiac surgery under CPB with preoperative PHT defined as mean pulmonary artery pressure (MPAP) over 30 mmHg or
- •systolic pulmonary artery pressure (SPAP) over 40 mmHg (using preoperative right-sided catheterization or estimated by echocardiography).
排除标准
- •Cardiac surgery not requiring CPB, contraindication to TEE (esophageal pathology or unstable cervical spine) and emergency surgery.
- •Patients will be recruited the day before surgery and randomized using computerized cards by the pharmacy department
研究组 & 干预措施
Normal saline
Normal saline by inhalation over 15 min
干预措施: Normal saline (Drug)
Milrinone
Inhaled milrinone 5 mg(as for the injectable solution)
干预措施: Milrinone (Drug)
结局指标
主要结局
To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass
时间窗: End of CPB
次要结局
- Reduction in morbidity and mortality post-op(At discharge, 3 months, 6 months and 1 year by telephone)
- Reduction in pulmonary artery pressure(Same day before and after CPB)
- Right ventricular function measured using transthoracic echocardiography (TTE) and TEE(Same day before and after the CPB)
- reduction of the composite index of hemodynamic complications (defined as hospital death, vasoactive drugs > 24 hours and post-op cardiac arrest),(24 hrs post op and hospital discharge)
- Serum levels of milrinone in relation with the pharmacodynamic marker(Same day pre CPB per CPB and post CPB)
研究者
Andre Denault
MD FRCPC ABIM-CCM
Montreal Heart Institute