Intravenous sildenafil for postoperative pulmonary hypertension in children with congenital heart diseaseReport as inadecuate




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Intensive Care Medicine

, Volume 37, Issue 3, pp 502–509

First Online: 11 November 2010Received: 02 July 2009Accepted: 06 October 2010

Abstract

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

MethodsA 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.

ResultsThe 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 ± standard deviation systolic pulmonary artery pressure was reduced with sildenafil 46 ± 11 to 35 ± 6 mmHg, p = 0.027 versus placebo. No adverse events or systemic hypotension were attributed to sildenafil.

ConclusionIntravenous sildenafil reduced pulmonary artery pressure and shortened time to extubation and intensive care unit stay in children with postoperative PH.

KeywordsCongenital heart disease Pulmonary arterial hypertension Postoperative management Pulmonary vasodilatation Electronic supplementary materialThe online version of this article doi:10.1007-s00134-010-2065-4 contains supplementary material, which is available to authorized users.

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Author: Alain Fraisse - Ghazwan Butrous - Mary B. Taylor - Michael Oakes - Maria Dilleen - David L. Wessel

Source: https://link.springer.com/







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