Effect of recombinant surfactant protein C-based surfactant on the acute respiratory distress syndrome
(2004) New England Journal of Medicine — Vol. 351, n° 9, p. 884-892 (2004)
Files
40039.pdf
Restricted Access - Adobe PDF
- 113.12 KB
Details
- Authors
- 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.
- Affiliations
Citations
Spragg, R., Laterre, P.-F., Lewis, J., Walmrath, H., Johannigman, J., Bellingan, G., Witte, M., Richards, G., Rippin, G., Rathgeb, F., Hafner, D., Taut, F., & Seeger, W. (2004). Effect of recombinant surfactant protein C-based surfactant on the acute respiratory distress syndrome. New England Journal of Medicine, 351(9), 884-892. https://doi.org/10.1056/NEJMoa033181 (Original work published 2004)