Aerosolized prostacyclin for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS)

Background Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are critical conditions that are associated with high mortality and morbidity. Aerosolized prostacyclin has been used to improve oxygenation despite the limited evidence available so far. Objectives To systematically assess the benefits and harms of aerosolized prostacyclin in critically ill patients with ALI and ARDS. Search strategy We identified randomized clinical trials (RCTs) from electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 1); MEDLINE; EMBASE; Science Citation Index Expanded; International Web of Science; CINAHL; LILACS; and the Chinese Biomedical Literature Database (to 31st January 2010). We contacted trial authors and manufacturers in the field. Selection criteria We included all RCTs, irrespective of blinding or language, that compared aerosolized prostacyclin with no intervention or placebo in either children or adults with ALI or ARDS. Data collection and analysis Two authors independently abstracted data and resolved any disagreements by discussion. We presented pooled estimates of the intervention effects as relative risks (RR) with 95% confidence intervals (CI) for dichotomous outcomes. Our primary outcome measure was all cause mortality. We planned to perform subgroup and sensitivity analyses to assess the effect of aerosolized prostacyclin in adults and children, and on various clinical and physiological outcomes. We assessed the risk of bias through assessment of methodological trial components and the risk of random error through trial sequential analysis. Main results We included one paediatric RCT with low risk of bias and involving a total of 14 critically ill children with ALI or ARDS. Aersosolized prostacyclin over less than 24 hours did not reduce overall mortality at 28 days (RR 1.50, 95% CI 0.17 to 12.94) compared with aerosolized saline (a total of three deaths). The authors did not encounter any adverse events such as bleeding or organ dysfunction. We were unable to perform the prespecified subgroups and sensitivity analyses or trial sequential analysis due to the limited number of RCTs. We were also not able to assess the safety and efficacy of aerosolized prostacyclin for ALI and ARDS. We found two ongoing trials, one involving adults and the other paediatric participants. The adult trial has been finalized but the data are not yet available. Authors' conclusions 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.