| 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 |
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| 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 |
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| 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) |
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| 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 |