ARDS Network 2002

Methods	n = 235, 10 centres Allocation concealment: central randomization Baseline similarity: age, APACHE III, sepsis Blinding: caregivers, study coordinators, investigators Cointerventions: lung protective ventilation studied in factorial design in 194 patients and applied to all patients subsequently enrolled; screening for ability to wean and weaning protocol standardized Withdrawals: none Losses to follow‐up: unclear
Participants	Inclusions: Mechanical ventilation; AECC definition for ALI and ARDS; duration of ALI or ARDS < 36 hours Exclusions: Neurologic disease impairing weaning, chronic lung disease, morbid obesity, liver disease; immunocompromised; burns; increased intracranial pressure
Interventions	IV lisofylline 3 mg/kg (maximum 300 mg) every 6 hours for 20 days or until 48 hours of unassisted breathing, or placebo
Outcomes	28 day mortality: RR 1.31 (95% CI 0.87 to 1.98) Ventilator free days to day 28 (median): 9 (lisofylline group); 11 (placebo group); p = 0.62 Adverse events leading to discontinuation of therapy not reported Severe adverse events: "no significant difference"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate