Safety and potential efficacy of an aerosolized surfactant in human sepsis-induced adult respiratory distress syndrome.

Autor: Weg JG, Balk RA, Tharratt RS, Jenkinson SG, Shah JB, Zaccardelli D, Horton J, Pattishall EN, Exosurf ARDS Sepsis Study Group, Weg, J G, Balk, R A, Tharratt, R S, Jenkinson, S G, Shah, J B, Zaccardelli, D, Horton, J, Pattishall, E N
Zdroj: JAMA: Journal of the American Medical Association; 11/9/94, Vol. 272 Issue 18, p1433-1438, 6p
Abstrakt: Objective: To evaluate the safety and potential efficacy of aerosolized surfactant in intubated patients with adult respiratory distress syndrome (ARDS).Design: A prospective, double-blind, placebo-controlled, randomized, parallel, multicenter pilot clinical trial.Patients: A total of 51 patients with sepsis-induced ARDS were entered into the study within 18 hours of developing sepsis or sepsis syndrome.Intervention: Patients were randomized into four treatment groups in a 2:1:2:1 ratio, as follows: 12 hours of surfactant per day, 12 hours of 0.6% saline per day, 24 hours of surfactant per day, and 24 hours of 0.6% saline per day. Surfactant or saline was aerosolized continuously for up to 5 days using an in-line nebulizer that aerosolized only during inspiration.Main Outcome Measures: Ventilatory data, arterial blood gases, and hemodynamic parameters were measured at baseline, every 4 or 8 hours during the 5 days of treatment, 24 hours after treatment, and 30 days after treatment, at which time mortality was also assessed. Safety was evaluated throughout the 30 days of the study.Results: Surfactant was administered safely in ventilated patients when given continuously throughout the 5 days using the nebulizer system. Although there were no differences in any physiological parameters between the treatment groups, there was a dose-dependent trend in reduction of mortality from 47% in the combined placebo group to 41% and 35% in the groups treated with 12 hours and 24 hours of surfactant per day, respectively.Conclusions: Aerosolized surfactant was well tolerated when administered on a continuous basis for up to 5 days; however, at the doses given, it did not result in significant improvements in patients with sepsis-induced ARDS. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index