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Previous Volume 351:884-892 August 26, 2004 Number 9 Next

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ABSTRACT

Background Preclinical 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.

Methods In 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.

Results The 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.

Conclusions The 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.

Source Information

From the University of California at San Diego, San Diego (R.G.S.); the University of Western Ontario, London, Ont., Canada (J.F.L.); Justus Liebig-University, Giessen, Germany (H.-D.W., W.S.); the University of Cincinnati Hospital, Cincinnati (J.J.); the Department of Medicine, University College London, London (G.B.); St. Luc University Hospital, Brussels (P.-F.L.); Mercy Medical Center, Des Moines, Iowa (M.C.W.); University of the Witwatersrand, Johannesburg (G.A.R.); Omnicare Clinical Research, Cologne, Germany (G.R.); and Altana Pharma, Konstanz, Germany (F.R., D.H., F.J.H.T.).

Address reprint requests to Dr. Spragg at the University of California at San Diego Veterans Affairs Medical Center, 3350 La Jolla Village Dr., San Diego, CA 92014, or at rspragg{at}ucsd.edu, or to Dr. Seeger at werner.seeger{at}innere.med.uni-giessen.de.

Full Text of this Article

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Surfactant Replacement
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Extract | Full Text | PDF  
N Engl J Med 2004; 351:2657, Dec 16, 2004. Correspondence

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