Trial reportIntensive care medicine2011
Intravenous sildenafil for postoperative pulmonary hypertension in children with congenital heart disease.
Trial report in Intensive care medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 93 citations in OpenAlex.
- Sildenafil for congenital heart diseases induced pulmonary hypertension, a meta-analysis of randomized controlled trials.BMC pediatrics · 2023Pooled it
- Pediatric Cardiac Intensive Care Society 2014 Consensus Statement: Pharmacotherapies in Cardiac Critical Care Pulmonary Hypertension.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2016Guideline
- Effect of Sildenafil on Pressure-Volume Loop Measures of Ventricular Function in Fontan Patients.Pediatric cardiology · 2016Trial
- Does intravenous sildenafil clinically ameliorate pulmonary hypertension during perioperative management of congenital heart diseases in children? - a prospective randomized study.Annals of cardiac anaesthesiaTrial
- Using Pharmacokinetic Modeling and Electronic Health Record Data to Predict Clinical and Safety Outcomes after Methylprednisolone Exposure during Cardiopulmonary Bypass in Neonates.Congenital heart disease · 2023Article
- Pediatric Pulmonary Hypertension: Definitions, Mechanisms, Diagnosis, and Treatment.Comprehensive Physiology · 2021Article
- The Efficacy and Safety of Pulmonary Vasodilators in Pediatric Pulmonary Hypertension (PH): A Systematic Review and Meta-analysis.Frontiers in pharmacology · 2021Article
- Drug Treatment of Pulmonary Hypertension in Children.Paediatric drugs · 2020Review
- Development of nanotechnology in andrology.Translational andrology and urology · 2020Review
- Management of Pulmonary Arterial Hypertension in the Pediatric Patient.Current cardiology reports · 2019Review
- EXPRESS: Parameters associated with outcome in pediatric patients with congenital heart disease and pulmonary hypertension subjected to combined vasodilator and surgical treatments.Pulmonary circulation · 2019Article
- Successful Surgical Repair and Perioperative Management of 6-Month-Old With Total Anomalous Pulmonary Venous Return in a Developing Country: Considerations for the Treatment of Pulmonary Hypertension.Cardiology research · 2018Article
- Treatment of pulmonary arterial hypertension in children.Nature reviews. Cardiology · 2015Review
- Substantially increased sildenafil bioavailability after sublingual administration in children with congenital heart disease: two case reports.Journal of medical case reports · 2014Article
- Safety of sildenafil in infants*.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2014Review
- Perioperative pharmacological management of pulmonary hypertensive crisis during congenital heart surgery.Pulmonary circulation · 2014Review
- Drug treatment of pulmonary hypertension in children.Paediatric drugs · 2014Review
- The role of phosphodiesterase inhibitors in the management of pulmonary vascular diseases.Global cardiology science & practice · 2014Article
- Preparation, characterization and optimization of sildenafil citrate loaded PLGA nanoparticles by statistical factorial design.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2013Article
- Current challenges in pediatric pulmonary hypertension.Seminars in respiratory and critical care medicine · 2013Review
Corrections and comments
- Commented on by
Authors and funding
6 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.