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. 2004 Oct 18;2004(4):CD004477. doi: 10.1002/14651858.CD004477.pub2
Methods n = 350, 47 centres
Allocation concealment: not described
Baseline similarity: age (D), APACHE II, sepsis
Blinding: caregivers
Cointerventions: initiation of weaning standardized; corticosteroids given to 25% of treatment patients and 26% of control patients
Withdrawals: treatment (1/178), control (1/172)
Losses to follow‐up: treatment (1/178), control (1/172)
Participants Inclusions: AECC definition for ARDS; duration of ARDS < 24 hours
Exclusions: Recent MI; liver or renal failure; neurogenic pulmonary edema
Interventions IV liposomal PGE1, dose titrated to 3.6 mcg/kg every 6 hours (14.4 mcg/kg/day) for 7 days, or placebo
Outcomes 28 day mortality: RR 1.10 (95% CI 0.80 to 1.51), based on data from 346 patients
Duration of ventilation (median days): 16.9 (PGE1 group); 19.6 (placebo group); p = 0.94
Adverse events leading to discontinuation of therapy (mainly hypotension and hypoxia): treatment (20/178 patients), control (1/172 patients)
Other safety data: drug‐related adverse events more common in treatment group (hypotension‐ treatment: 93/178 patients, control: 29/172 patients; hypoxia‐ treatment: 43/178 patients, control: 9/172 patients); no difference in incidence of serious adverse events
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear