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. 2004 Oct 18;2004(4):CD004477. doi: 10.1002/14651858.CD004477.pub2
Methods n = 48, 5 centres
Allocation concealment: sequentially numbered drug packs
Baseline similarity: age, APACHE II
Blinding: caregivers, investigating team
Cointerventions: not described
Withdrawals: NAC (2/16), procysteine (none), control (none). Mortality information for one withdrawn patient who received NAC was available and included in the analysis.
Losses to follow‐up: none
Participants Inclusions: Mechanical ventilation; bilateral CXR infiltrates, no LAH, P/F of 200 mmHg or less or 225 mmHg or less if PEEP > 10 cmH2O; duration of ARDS < 24 h
Exclusions: Severe acute or chronic liver disease; immunocompromised
Interventions IV NAC, 70 mg/kg every 8 hours for 10 days (total dose 2100 mg/kg), or IV procysteine, 63 mg/kg every 8 hours for 10 days, or placebo
Outcomes 30 day mortality (NAC versus control): RR 0.83 (95% CI 0.32 to 2.15)
30 day mortality (procysteine versus control): RR 0.88 (95% CI 0.36 to 2.16)
Ventilator free days to day 30 (median): 11 (NAC group); 20 (procysteine group); 3 (placebo group); differences not significant at p = 0.05 level
Adverse events attributed to study medication: none
Notes Patients (n = 48) were randomized to receive NAC (n = 16), procysteine (n = 17), or placebo (n = 15).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate