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. 2004 Oct 18;2004(4):CD004477. doi: 10.1002/14651858.CD004477.pub2
Methods n = 725, 63 centres
Allocation concealment: central randomization
Baseline similarity: age, APACHE III (A), sepsis
Blinding: caregivers
Cointerventions: not described
Withdrawals: none
Losses to follow‐up: none
Participants Inclusions: Risk factor: sepsis or sepsis syndrome present for < 96 hours; diffuse CXR infiltrates, P/F < 250 mmHg, no left ventricular failure; mechanical ventilation; duration of ARDS < 48 hours
Exclusions: Chronic lung, liver or renal disease; acute liver failure; HIV with Pneumocystis carinii pneumonia; inhalational injury
Interventions Continuously aerosolized synthetic surfactant (Exosurf) with DPPC 13.5 mg/ml) 240 ml daily for 5 days (estimated aerosolized DPPC: 112 mg/kg/d), or placebo (nebulized 0.45% saline)
Outcomes 30 day mortality: RR 1.01 (95% CI 0.84 to 1.20)
Duration of ventilation: MD ‐0.40 days (95% CI ‐3.04 to 2.24)
Adverse events leading to discontinuation of therapy not reported
Serious adverse events: treatment: 5/364 (hypotension, barotrauma, hypoxaemia, increased peak airway pressure, respiratory arrest); control: 3/361 (hypotension, barotrauma)
Notes Duration of ventilation was reported as 16.0 (1.0) days for the surfactant group and 16.4 (0.9) days for the placebo group. Although the authors reported the duration of ventilation as mean (standard deviation), the standard deviations were extremely small and we assumed that they were standard errors of the mean.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate