| Methods | n = 40, 11 centres Allocation concealment: central randomization Baseline similarity: age, modified APACHE II, sepsis Blinding: caregivers unblinded (no placebo) Cointerventions: daily screening for ability to wean Withdrawals: none Losses to follow‐up: none |
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| Participants | Inclusions: Risk factor for ARDS; AECC definition of ARDS; duration of ARDS not more than 48 hours; PEEP of at least 5 cmH20; at least 48 hours of antimicrobial therapy if pneumonia present Exclusions: Hemodynamic instability; severe hypoxaemia; lung cancer; AIDS |
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| Interventions | Intratracheal synthetic surfactant (Venticute, containing 1 mg recombinant surfactant protein C and 50 mg phospholipids per ml), 1 ml/kg up to 4 doses in 24 hours, or 0.5 mL/kg up to 4 doses in 24 hours, or standard therapy | |
| Outcomes | 28 day mortality (all surfactant doses versus control): RR 0.67 (95% CI 0.26 to 1.72) Ventilator‐free days to day 28 [median (interquartile range)]: low dose: 4 (0 to 12); high dose 5 (0 to 18); control: 6 (0 to 15); differences reported to be non significant Adverse events leading to discontinuation of therapy: none Other safety data: treatment: 1/27 patients had an adverse event likely related to treatment (transient hypoxia and supraventricular tachycardia); no difference in incidence of serious adverse events |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |