Intravenous sildenafil for postoperative pulmonary hypertension in children with congenital heart disease.

ABSTRACT:

Purpose

To evaluate the efficacy and safety of intravenous sildenafil for immediate postoperative pulmonary hypertension (PH) in pediatric patients undergoing congenital heart surgery.

Methods

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.

Results

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 p

SUBMITTER: Fraisse A 

PROVIDER: S-EPMC3042092 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature