• Roger G Spragg, James F Lewis, Hans-Dieter Walmrath, Jay Johannigman, Geoff Bellingan, Pierre-Francois Laterre, Michael C Witte, Guy A Richards, Gerd Rippin, Frank Rathgeb, Dietrich Häfner, Friedemann J H Taut, and Werner Seeger.
• University of California at San Diego, Veterans Affairs Medical Center, San Diego 92014, USA. rspragg@ucsd.edu
• N. Engl. J. Med. 2004 Aug 26;351(9):884-92.

BackgroundPreclinical studies suggest that exogenous surfactant may be of value in the treatment of the acute respiratory distress syndrome (ARDS), and two phase 2 clinical trials have shown a trend toward benefit. We conducted two phase 3 studies of a protein-containing surfactant in adults with ARDS.MethodsIn two multicenter, randomized, double-blind trials involving 448 patients with ARDS from various causes, we compared standard therapy alone with standard therapy plus up to four intratracheal doses of a recombinant surfactant protein C-based surfactant given within a period of 24 hours.ResultsThe overall survival rate was 66 percent 28 days after treatment, and the median number of ventilator-free days was 0 (68 percent range, 0 to 26); there was no significant difference between the groups in terms of mortality or the need for mechanical ventilation. Patients receiving surfactant had a significantly greater improvement in blood oxygenation during the initial 24 hours of treatment than patients receiving standard therapy, according to both univariate and multivariate analyses.ConclusionsThe use of exogenous surfactant in a heterogeneous population of patients with ARDS did not improve survival. Patients who received surfactant had a greater improvement in gas exchange during the 24-hour treatment period than patients who received standard therapy alone, suggesting the potential benefit of a longer treatment course.Copyright 2004 Massachusetts Medical Society

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