| 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) |
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| Participants | Inclusions: AECC definition for ARDS; duration of ARDS < 24 hours Exclusions: Recent MI; liver or renal failure; neurogenic pulmonary edema |
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| 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 |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |