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. 2004 Oct 18;2004(4):CD004477. doi: 10.1002/14651858.CD004477.pub2
Methods n = 18, 1 centre
Allocation concealment: presupplied randomized drug packs
Baseline similarity: age (D), APACHE II, duration of ventilation
Blinding: caregivers, data collectors
Cointerventions: Level of PEEP and tidal volumes similar in two groups
Withdrawals: none
Losses to follow‐up: none
Participants Inclusions: Risk factor: severe sepsis; CXR infiltrate, PaO2 < 60 mmHg on room air or P/F < 287 mmHg
Exclusions: Malignancy, immunosuppression
Interventions IV GM‐CSF, 3 mcg/kg daily for 5 days, or placebo
Outcomes Hospital mortality: RR 1.33 (95% CI 0.45 to 3.96)
Adverse events leading to discontinuation of therapy: treatment: 1/10 (transient oliguria), control: 0/8
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate