期刊
INTENSIVE CARE MEDICINE
卷 37, 期 3, 页码 502-509出版社
SPRINGER
DOI: 10.1007/s00134-010-2065-4
关键词
Congenital heart disease; Pulmonary arterial hypertension; Postoperative management; Pulmonary vasodilatation
资金
- Pfizer Inc.
To evaluate the efficacy and safety of intravenous sildenafil for immediate postoperative pulmonary hypertension (PH) in pediatric patients undergoing congenital heart surgery. A double-blind, multicenter, placebo-controlled, dose-ranging, parallel-group trial was conducted. Patients were randomized to one of three doses of intravenous sildenafil, or placebo, for a minimum of 24 h. The study was heavily underpowered. Whereas enrollment of 228 patients (57 per treatment arm) was required to achieve the sample size estimate to detect difference between arms, the sponsor terminated the study after 15 months owing to slow patient accrual. Seventeen patients (median age 5 months) experiencing postoperative PH were randomized and treated, five with placebo and four each with low-, medium-, and high-dose sildenafil. In the first 24 h, 40% of placebo and 17% of sildenafil patients required additional therapy (p = 0.330). Median time to extubation (3 versus 8 days, p = 0.023) and intensive care unit stay (6 versus 15 days, p = 0.008) were shorter for sildenafil patients. Mean +/- A standard deviation systolic pulmonary artery pressure was reduced with sildenafil (46 +/- A 11 to 35 +/- A 6 mmHg, p = 0.027 versus placebo). No adverse events or systemic hypotension were attributed to sildenafil. Intravenous sildenafil reduced pulmonary artery pressure and shortened time to extubation and intensive care unit stay in children with postoperative PH.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据