Randomized controlled trial of aerosolized prostacyclin therapy in children with acute lung injury.
OBJECTIVE
To investigate whether aerosolized prostacyclin improves oxygenation in children with acute lung injury.


METHODS
Double-blind, randomized, and placebo-controlled trial.


METHODS
Pediatric intensive care unit at a university hospital.


METHODS
Fourteen children with acute lung injury defined by the criteria of an American-European Consensus Conference.


METHODS
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).


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.
Dahlem
Peter
P
Division of Pediatric Intensive Care, Department of Pediatrics, Emma Children's Hospital, Academic Medical Center of the University of Amsterdam, The Netherlands.
van Aalderen
Wim M C
WM
de Neef
Marjorie
M
Dijkgraaf
Marcel G W
MG
Bos
Albert P
AP
D000280:Administration, Inhalation; D000336:Aerosols; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D003288:Contusions / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D011464:Epoprostenol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007223:Infant; D015278:Intensive Care Units, Pediatric; D055370:Lung Injury; D008176:Lung Volume Measurements; D008297:Male; D009104:Multiple Trauma / Q000188:drug therapy*; D010100:Oxygen / Q000097:blood; D012121:Respiration, Artificial; D012128:Respiratory Distress Syndrome / Q000188:drug therapy*
D000336:Aerosols; D000959:Antihypertensive Agents; D011464:Epoprostenol; D010100:Oxygen