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Randomized controlled trial of aerosolized prostacyclin therapy in children with acute lung injury
Peter Dahlem1, Wim M C van Aalderen, Marjorie de Neef
1Division of Pediatric Intensive Care, Department of Pediatrics, Emma Children's Hospital, Academic Medical Center of the University of Amsterdam, The Netherlands.
Insights
Aerosolized prostacyclin significantly improved oxygenation in children with acute lung injury. This treatment showed a 26% increase in the oxygenation index, with no observed adverse effects, suggesting potential therapeutic benefits.
Area of Science:
- Pediatric Critical Care Medicine
- Pulmonary Medicine
- Pharmacology
Background:
- Acute lung injury (ALI) in children presents a significant challenge in pediatric intensive care.
- Effective oxygenation strategies are crucial for improving outcomes in pediatric ALI.
- Prostacyclin, a vasodilator, has potential but unproven benefits in pediatric ALI.
Purpose of the Study:
- To evaluate the efficacy of aerosolized prostacyclin in improving oxygenation in pediatric patients with acute lung injury.
- To determine the optimal dosage of aerosolized prostacyclin for oxygenation improvement.
- To assess the safety and tolerability of aerosolized prostacyclin in this population.
Main Methods:
- A double-blind, randomized, placebo-controlled trial was conducted in a university hospital's pediatric intensive care unit.
- Fourteen children meeting American-European Consensus Conference criteria for ALI received aerosolized prostacyclin or placebo.
- Doses of aerosolized prostacyclin were administered in stepwise increments (10-50 ng x kg x min), with oxygenation index and arterial blood gases monitored.
Main Results:
- A significant 26% improvement in the oxygenation index was observed with aerosolized prostacyclin at 30 ng x kg x min compared to placebo (p =.001).
- Eight out of 14 children (responders) showed a greater than or equal to 20% improvement in oxygenation.
- The number needed to treat was 1.8, and no adverse effects were reported during the study.
Conclusions:
- Aerosolized prostacyclin is effective in improving oxygenation in pediatric patients suffering from acute lung injury.
- The findings support further investigation into the impact of aerosolized prostacyclin on clinical outcomes in pediatric ALI.
- This therapeutic approach warrants consideration in managing children with acute lung injury and hypoxemia.
Objectives:
To investigate whether aerosolized prostacyclin improves oxygenation in children with acute lung injury.
Design:
Double-blind, randomized, and placebo-controlled trial.
Setting:
Pediatric intensive care unit at a university hospital.
Patients:
Fourteen children with acute lung injury defined by the criteria of an American-European Consensus Conference.
Interventions:
Aerosolized prostacyclin (epoprostenol sodium) by stepwise increments of different doses (10, 20, 30, 40, and 50 ng x kg x min) vs. aerosolized normal saline (placebo).
Measurements And Main Results:
Before the start of the study, and before and after each dose of prostacyclin/placebo, the following variables were measured: arterial blood gases, heart rate, mean arterial blood pressure, and ventilator settings required. Changes in oxygenation were measured by calculation of the oxygenation index (mean airway pressure x 100 x Pao2/Fio2). After treatment with aerosolized prostacyclin, there was a significant 26% (interquartile range, 3%, 35%) improvement in oxygenation index at 30 ng x kg x min compared with placebo (p =.001). The response to prostacyclin was not the same in all children. We saw an improvement of > or = 20% in eight of 14 children (i.e., responders), and the number needed to treat was 1.8 (95% confidence interval, 1.2-3.2). No adverse effects were observed.
Conclusions:
Aerosolized prostacyclin improves oxygenation in children with acute lung injury. Future trials should investigate whether this treatment will positively affect outcome.
