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Original Research: Critical Care |

The Adult Calfactant in Acute Respiratory Distress Syndrome TrialCARDS Adult Trial

Douglas F. Willson, MD; Jonathon D. Truwit, MD, MBA; Mark R. Conaway, PhD; Christine S. Traul, MD; Edmund E. Egan, MD
Author and Funding Information

From the Department of Pediatrics (Dr Willson), Medical College of Virginia, Virginia Commonwealth University, Richmond, VA; Division of Pulmonary and Critical Care Medicine (Dr Truwit), Froedtert & the Medical College of Wisconsin, Milwaukee, WI; Department of Health Evaluation Sciences (Dr Conaway), University of Virginia Health Sciences System, Charlottesville, VA; Department of Pediatrics (Dr Traul), Cleveland Clinic Children’s, Cleveland, OH; Pneuma Pharmaceuticals (Dr Egan), Amherst, NY; and University at Buffalo (Dr Egan), The State University of New York, Buffalo, NY.

CORRESPONDENCE TO: Douglas F. Willson, MD, Department of Pediatrics, Children’s Hospital of Richmond at VCU, Old City Hall, 2nd Fl, Ste 205A, 1001 E Broad St, Richmond, VA 23219; e-mail: dwillson@mcvh-vcu.edu


Drs Willson and Truwit are co-first authors.

FUNDING/SUPPORT: This work was supported by Pneuma Pharmaceuticals (Amherst, NY).

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2015;148(2):356-364. doi:10.1378/chest.14-1139
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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.

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