| Methods | n = 24, 4 centres Allocation concealment: not described Baseline similarity: age, MODS, sepsis; analyses adjusted for variables used to calculate severity of illness scores Blinding: caregivers Cointerventions: lung protective ventilation (limitation of plateau pressure to 35 cmH20) used in both groups Withdrawals: none Losses to follow‐up: none |
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| Participants | Inclusions: AECC definition for ARDS; at least 7 days of mechanical ventilation; lung injury score at least 2.5 with a reduction of less than 1 point from day 1 of ARDS Exclusions: ARDS of 3 or more weeks' duration; untreated infection; burns; recent gastrointestinal bleed |
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| Interventions | IV methylprednisolone, 2 mg/kg/day IV for 14 days, tapering to zero over the next 18 days, or placebo | |
| Outcomes | ICU mortality: 0/16 (methylprednisolone group) and 5/8 (placebo group); RR 0.05 (95% CI 0 to 0.78) Hospital mortality: 2/16 (methylprednisolone group) and 5/8 (placebo group); RR 0.20 (95% CI 0.05 to 0.81) Duration of ventilation (median days): 11.5 (methylprednisolone group); 23 (placebo group); p = 0.001 Adverse events leading to discontinuation of therapy not reported Other safety data: infections per 100 patient‐days of treatment: 8 (methylprednisolone group); 7 (placebo group) |
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| Notes | The mean duration of ARDS at randomization was 9.4 days (standard error 0.9 days) in the methyprednisolone group and 8.8 days (standard error 1.2 days) in the placebo group. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |