The Adult Calfactant in Acute Respiratory Distress Syndrome Trial. Chest 2015 Aug;148(2):356-364
Date
04/10/2015Pubmed ID
25855884DOI
10.1378/chest.14-1139Scopus ID
2-s2.0-84939228194 (requires institutional sign-in at Scopus site) 64 CitationsAbstract
BACKGROUND: Surfactant has been shown to be dysfunctional in ARDS, and exogenous surfactant has proven effective in many forms of neonatal and pediatric acute lung injury (ALI). In view of the positive results of our studies in children along with evidence that surfactant-associated protein B containing pharmaceutical surfactants might be more effective, we designed a multiinstitutional, randomized, controlled, and masked trial of calfactant, a calf lung surfactant, in adults and children with ALI/ARDS due to direct lung injury.
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.
Author List
Willson DF, Truwit JD, Conaway MR, Traul CS, Egan EEMESH terms used to index this publication - Major topics in bold
AdultAged
Biological Products
Double-Blind Method
Early Termination of Clinical Trials
Female
Humans
Hypotension
Hypoxia
Length of Stay
Male
Middle Aged
Oximetry
Pulmonary Surfactants
Respiration, Artificial
Treatment Outcome