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. 2004 Oct 18;2004(4):CD004477. doi: 10.1002/14651858.CD004477.pub2
Methods n = 25, 8 centres
Allocation concealment: not described
Baseline similarity: age (D), APACHE II, sepsis
Blinding: caregivers
Cointerventions: not described
Withdrawals: none
Losses to follow‐up: none
Participants Inclusions: Mechanical ventilation; bilateral CXR infiltrates, no LAH, P/F of 225 mmHg or less; 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 0.24 (95% CI 0.02 to 2.23)
Adverse events leading to discontinuation of therapy: treatment: 1/17 (desaturation and dysrhythmia), control: 0/8
Other safety data: any medication‐related adverse event (treatment: 14/17 patients, control: 3/8 patients); infusion site irritation, transient desaturation and agitation were reported in some treatment but no control patients; no serious adverse event in either group was considered related to study medication
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear