Randomized controlled trial of aerosolized prostacyclin therapy in children with acute lung injury.
To investigate whether aerosolized prostacyclin improves oxygenation in children with acute lung injury.
                Double-blind, randomized, and placebo-controlled trial.
                Pediatric intensive care unit at a university hospital.
                Fourteen children with acute lung injury defined by the criteria of an American-European Consensus Conference.
                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).
                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.
                Aerosolized prostacyclin improves oxygenation in children with acute lung injury. Future trials should investigate whether this treatment will positively affect outcome.
There is no current evidence to support or refute the routine use of aerosolized prostacyclin for patients with ALI and ARDS. There is an urgent need for more randomized clinical trials.