Phase 2 Use of Sildenafil for the Treatment of Post-capillary Hypertension in Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- reduced mechanical ventilation
研究概览
简要总结
Pulmonary hypertension increases the perioperative risk in patients undergoing cardiac surgery for valvular heart diseases, especially in patients with a long life mitral valve disease. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle.
详细描述
Pulmonary hypertension represents an increased risk for perioperative patients undergoing cardiac surgery for valvular heart disease especially in patients with a long life mitral valve disease complicated by sever pulmonary hypertension, with high risk of developing post operative right ventricular failure during separation from cardiopulmonary by pass. A recent study showed that a single oral administration of sildenafil at the beginning of the cardiac intervention in patients undergoing valvular heart surgery complicated by pulmonary hypertension reduces pulmonary vascular resistances without inducing significant effects on systemic vascular resistances. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle avoiding right ventricular failure. This should support weaning from cardiopulmonary by pass in patients undergoing cardiac surgery for valvular heart diseases associated to pulmonary hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •all patients undergoing valvular heart surgery associated to post capillary pulmonary hypertension with a mean pulmonary arterial pressure (mPAP)>30mmHg or pulmonary vascular resistance (PVR)>3Wu.
排除标准
- •patients younger than 18 years old
- •ischemic cardiomyopathy
- •Ejection Fraction (EF)<30%
- •severe Chronic obstructive pulmonary disease (COPD) with oxygen and bronchodilators therapy
- •chronic pulmonary disease, chronic renal failure on dialysis
- •hepatic failure
- •patients with orotracheal intubation and already admitted to the ICU before the intervention
研究组 & 干预措施
Sildenafil
All patient will be treat with a intravenous administration of the drug from the beginning of the intervention, for a maximum of 72 hours.
干预措施: sildenafil (Drug)
结局指标
主要结局
reduced mechanical ventilation
时间窗: seven days
The primary outcome is the reduction of time on mechanical ventilation
次要结局
- ICU length of stay(28 days)
研究者
Daniela Pasero
Medical Doctor
University of Turin, Italy