| 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 |
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| 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 |
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| 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 |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |