Effect of recombinant surfactant protein C-based surfactant on the acute respiratory distress syndrome.
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.
University of California at San Diego, Veterans Affairs Medical Center, San Diego 92014, USA. rspragg@ucsd.edu
Roger G
RG
Spragg
James F
JF
Lewis
Hans-Dieter
HD
Walmrath
Jay
J
Johannigman
Geoff
G
Bellingan
Pierre-Francois
PF
Laterre
Michael C
MC
Witte
Guy A
GA
Richards
Gerd
G
Rippin
Frank
F
Rathgeb
Dietrich
D
Häfner
Friedemann J H
FJ
Taut
Werner
W
Seeger
D018806:APACHE; D000704:Analysis of Variance; D015984:Causality; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010100:Oxygen / Q000097:blood; D037721:Pulmonary Surfactant-Associated Protein C / Q000009:adverse effects / Q000627:therapeutic use*; D011663:Pulmonary Surfactants / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012121:Respiration, Artificial; D012128:Respiratory Distress Syndrome / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality / Q000628:therapy; D015996:Survival Rate; D017211:Treatment Failure
D037721:Pulmonary Surfactant-Associated Protein C; D011663:Pulmonary Surfactants; D011994:Recombinant Proteins; D010100:Oxygen