NCT01725776已完成2 期
Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients
Montreal Heart Institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Study the elimination rate of milrinone administered by inhalation
研究概览
简要总结
The purpose of this study is to investigate the concentration-effect relationship of inhaled milrinone after prophylactic administration in cardiac surgical patients with preoperative pulmonary hypertension undergoing cardiopulmonary bypass.
详细描述
Milrinone elimination will be verify with blood and urine samples analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients scheduled for elective cardiac surgery under CPB
- •High risk patients: NYHA class II-III
- •Preoperative diagnostic of pulmonary hypertension:
- •Systolic pulmonary artery pressure (sPAP) > 35 mm Hg; or
- •Mean pulmonary artery pressure (mPAP) > 25 mm Hg; or
- •mAP/mPAP < 3.0 (after induction of anesthesia).
排除标准
- •Open Heart Surgery
- •Contraindication to transesophageal echocardiography (TEE)
- •Hemodynamic instability before surgery
- •Emergency surgery
研究组 & 干预措施
Inhaled milrinone 5 mg
Experimental
Inhaled milrinone 5 mg(as for the injectable solution)
干预措施: Inhaled milrinone 5 mg (Drug)
结局指标
主要结局
Study the elimination rate of milrinone administered by inhalation
时间窗: up to 24 hours
次要结局
- Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone(15 min after the of study drug administration)
- Confirmation of the safety of inhaled milrinone(24 hours after cardiac surgery)
- Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension(15 min after end of milrinone administration)
研究者
Andre Denault
MD PhD FRCPC ABIM-CCM
Montreal Heart Institute
研究点 (1)
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