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. 2004 Oct 18;2004(4):CD004477. doi: 10.1002/14651858.CD004477.pub2
Methods n = 99, 7 centres
Allocation concealment: sequentially numbered drug packs
Baseline similarity: age (A), duration of ventilation (A), organ failures (A), sepsis
Blinding: caregivers, investigating team
Cointerventions: not described
Withdrawals: none
Losses to follow‐up: none
Participants Inclusions: Risk factor for ARDS; bilateral CXR infiltrates; PaO2 of 70 mmHg or less on FiO2 of at least 0.4, or PaO2/PAO2 of 0.3 or less; no LAH
Exclusions: Hypotension; burns; some infections
Interventions IV methylprednisolone,30 mg/kg IV every 6 hours for 4 doses, or placebo
Outcomes 45 day mortality: RR 0.95 (95% CI 0.69 to 1.29)
Adverse events leading to discontinuation of therapy not reported
Other safety information: infectious complications (treatment: 8/50, control: 5/49)
Notes Mean duration of mechanical ventilation before study entry was 2.8 days (standard error 0.5 days) in the methylprednisolone group and 1.9 days (standard error 0.4 days) in the placebo group.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate