Abstract | BACKGROUND: METHODS: Adult subjects within 48 h of initiation of mechanical ventilation for direct ARDS were randomized to receive up to three interventions with instilled calfactant vs air placebo. The primary outcome was 90-day all-cause mortality. RESULTS: Three hundred seventeen subjects were enrolled, 308 of whom could be evaluated. There were no significant baseline differences between groups. Calfactant administration was not associated with improved survival, lengths of stay, or oxygenation. Calfactant instillation was frequently associated with transient hypoxia and hypotension. The study was stopped at the first interim analysis at the sponsor's request. CONCLUSIONS: Administration of calfactant was not associated with improved oxygenation or longer-term benefits relative to placebo in this randomized, controlled, and masked trial. At present, exogenous surfactant cannot be recommended for routine clinical use in ARDS. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00682500; URL: www.clinicaltrials.gov.
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Authors | Douglas F Willson, Jonathon D Truwit, Mark R Conaway, Christine S Traul, Edmund E Egan |
Journal | Chest
(Chest)
Vol. 148
Issue 2
Pg. 356-364
(Aug 2015)
ISSN: 1931-3543 [Electronic] United States |
PMID | 25855884
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Biological Products
- Pulmonary Surfactants
- calfactant
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Topics |
- Adult
- Aged
- Biological Products
(therapeutic use)
- Double-Blind Method
- Early Termination of Clinical Trials
- Female
- Humans
- Hypotension
(chemically induced)
- Hypoxia
(chemically induced)
- Length of Stay
- Male
- Middle Aged
- Oximetry
- Pulmonary Surfactants
(therapeutic use)
- Respiration, Artificial
- Respiratory Distress Syndrome
(mortality, therapy)
- Treatment Outcome
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