title: The Adult Calfactant in Acute Respiratory Distress Syndrome Trial.
abstract: 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.
  
  
  BACKGROUND
  ClinicalTrials.gov; No.: NCT00682500; URL: www.clinicaltrials.gov.
authors: Department of Pediatrics, Medical College of Virginia, Virginia Commonwealth University, Richmond, VA. Electronic address: dwillson@mcvh-vcu.edu.
authors: Douglas F
authors: DF
authors: Willson
authors: Division of Pulmonary and Critical Care Medicine, Froedtert & the Medical College of Wisconsin, Milwaukee, WI.
authors: Jonathon D
authors: JD
authors: Truwit
authors: Department of Health Evaluation Sciences, University of Virginia Health Sciences System, Charlottesville, VA.
authors: Mark R
authors: MR
authors: Conaway
authors: Department of Pediatrics, Cleveland Clinic Children's, Cleveland, OH.
authors: Christine S
authors: CS
authors: Traul
authors: Pneuma Pharmaceuticals, Amherst, NY; University at Buffalo, The State University of New York, Buffalo, NY.
authors: Edmund E
authors: EE
authors: Egan
mesh_terms: D000328:Adult; D000368:Aged; D001688:Biological Products / Q000627:therapeutic use*; D004311:Double-Blind Method; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D007022:Hypotension / Q000139:chemically induced*; D000860:Hypoxia / Q000139:chemically induced*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010092:Oximetry; D011663:Pulmonary Surfactants / Q000627:therapeutic use*; D012121:Respiration, Artificial; D012128:Respiratory Distress Syndrome / Q000401:mortality / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D001688:Biological Products; D011663:Pulmonary Surfactants; C117342:calfactant