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. 2004 Oct 18;2004(4):CD004477. doi: 10.1002/14651858.CD004477.pub2
Methods n = 51, 20 centres
Allocation concealment: central randomization
Baseline similarity: age, APACHE II
Blinding: caregivers
Cointerventions: "no difference" in use of glucocorticoids or mineralocorticoids
Withdrawals: not described
Losses to follow‐up: not described
Participants Inclusions: Risk factor: sepsis or sepsis syndrome present < 18 hours; mechanical ventilation; bilateral CXR infiltrates, P/F 50‐299 mmHg
Exclusions: Chronic lung, liver or renal disease; AIDS; pulmonary infection; cardiac ischaemia or left ventricular failure
Interventions Continuously aerosolized synthetic surfactant (Exosurf) with DPPC 13.5 mg/ml, 175 ml every 4 hours for 12 hours/day or 24 hours/day for 5 days (estimated aerosolized DPPC: 21.9 and 43.5 mg/kg/day respectively), or placebo (nebulized 0.6% saline)
Outcomes 30 day mortality (all surfactant doses versus control): RR 0.81 (95% CI 0.42 to 1.57)
Adverse events leading to discontinuation of therapy not reported
Other safety data: treatment: pneumothorax (1/34 patients), clonus (1/34 patients); control: 0/17 patients had adverse events
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate