Randomized controlled trial of aerosolized prostacyclin therapy in children with
acute lung injury.
Author(s): Dahlem P(1), van Aalderen WM, de Neef M, Dijkgraaf MG, Bos AP.
Affiliation(s): Author information:
(1)Division of Pediatric Intensive Care, Department of Pediatrics, Emma
Children's Hospital, Academic Medical Center of the University of Amsterdam, The
Netherlands.
Publication date & source: 2004, Crit Care Med. , 32(4):1055-60
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.
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