The Adult Calfactant in Acute Respiratory Distress Syndrome (CARDS) Trial.
Chest. 2015 Apr 9;
Authors: Willson DF, Truwit JD, Conaway MR, Traul CS, Egan EE
Background: Surfactant has been shown to be dysfunctional in acute respiratory distress syndrome and exogenous surfactant has proven effective in many forms of neonatal and pediatric acute lung injury. In view of the positive results of our studies in children along with evidence that SP-B containing pharmaceutical surfactants might be more effective, we designed a multi-institutional, 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 hours of initiation of mechanical ventilation for direct acute respiratory distress syndrome were randomized to receive up to three interventions with instilled calfactant versus air placebo. The primary outcome was 90-day all cause mortality.
Results: 317 subjects were enrolled, 308 which 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 acute respiratory distress syndrome.
PMID: 25855884 [PubMed - as supplied by publisher]