What is the clinical evidence from this study?

Study design: RCT. Population: Postoperative pulmonary hypertension in congenital heart disease (n=17). Intervention: Intravenous sildenafil vs. Placebo. Primary outcome: Receipt of any additional therapy for treatment of postoperative PH within 24 h of start of study drug infusion (p=0.330).

What question did this study set out to answer?

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

November 10, 2010Intensive Care MedicineOpen Access

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

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Key result

In a heavily underpowered trial, intravenous sildenafil did not significantly reduce the need for additional therapy within 24 hours compared to placebo (17% vs 40%, p=0.330), though it did shorten time to extubation and ICU stay.

Why the study?

Does intravenous sildenafil improve clinical outcomes and reduce pulmonary artery pressure in pediatric patients with postoperative pulmonary hypertension after congenital heart surgery?

Key Points

To evaluate the efficacy and safety of intravenous sildenafil for treating immediate postoperative pulmonary hypertension in pediatric patients undergoing congenital heart surgery.
A multicenter, double-blind, placebo-controlled, dose-ranging, parallel-group trial randomized pediatric patients (median age 5 months) with postoperative pulmonary hypertension to receive placebo or one of three doses of intravenous sildenafil for at least 24 hours.
The trial planned an enrollment of 228 patients (57 per treatment arm) but was terminated early after 15 months due to slow patient accrual, resulting in a treated sample size of N=17 (placebo: n=5; low-, medium-, and high-dose sildenafil: n=4 each).
Systolic pulmonary artery pressure significantly decreased with sildenafil from 46 ± 11 mmHg to 35 ± 6 mmHg compared with placebo (p = 0.027).
Sildenafil significantly reduced median time to extubation (3 vs 8 days, p = 0.023) and median intensive care unit length of stay (6 vs 15 days, p = 0.008) compared with placebo.
Additional pulmonary hypertension therapy within the first 24 hours was required in 17% of sildenafil patients compared with 40% of placebo patients (p = 0.330), with no adverse events or systemic hypotension attributed to sildenafil.

Study Design

Type

RCT (n=17)

Blinding

Double-blind

Randomization

Automated interactive voice response system, stratified by age and study center

Multicenter

Yes

Structured PICO

Does intravenous sildenafil improve clinical outcomes and reduce pulmonary artery pressure in pediatric patients with postoperative pulmonary hypertension after congenital heart surgery?

Population

17 children (median age 5 months) with postoperative pulmonary hypertension following congenital heart surgery, randomized to intravenous sildenafil or placebo for 24 to 72 hours.

Intervention

Intravenous sildenafil (low-, medium-, or high-dose) for a minimum of 24 hours

Comparator

Placebo

Outcome

Efficacy (need for additional therapy in the first 24 hours, time to extubation, intensive care unit stay, systolic pulmonary artery pressure) and safety

Main Result

Absolute Event Rate: 17% vs 40%

p-value: p=0.330

Despite being heavily underpowered, intravenous sildenafil significantly reduced pulmonary artery pressure and shortened time to extubation and ICU stay in children with postoperative pulmonary hypertension.

Limitations

Premature closure of the trial due to slow patient accrual, resulting in a heavily underpowered study
Exclusion of patients emergently treated with a pulmonary vasodilator or ECMO
Exclusion of neonates and infants aged <60 days
Blood gas measurements and arterial PO2 were not regularly recorded
Heavily underpowered
Terminated early by sponsor after 15 months owing to slow patient accrual
Small sample size (n=17)

Discussion

No takes yet. Share an insight, caveat, or question.

Implication

Does not support intravenous sildenafil to reduce additional therapy needs; leaves open potential benefits on extubation and ICU stay in larger trials.

Cite This Study

Fraisse et al. (2010) conducted an RCT in Postoperative pulmonary hypertension in congenital heart disease (n=17). Intravenous sildenafil vs. Placebo was evaluated on Receipt of any additional therapy for treatment of postoperative PH within 24 h of start of study drug infusion (p=0.330). In a heavily underpowered trial, intravenous sildenafil did not significantly reduce the need for additional therapy within 24 hours compared to placebo (17% vs 40%, p=0.330), though it did shorten time to extubation and ICU stay.

synapsesocial.com/papers/6a6f3f31e71d69abee07ece5 https://doi.org/10.1007/s00134-010-2065-4

Topics

Congenital heart disease adults

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Implication

Does not support intravenous sildenafil to reduce additional therapy needs; leaves open potential benefits on extubation and ICU stay in larger trials.

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

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Topics

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

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider