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

Journal Article

To evaluate the safety and potential efficacy of aerosolized surfactant in intubated patients with adult respiratory distress syndrome (ARDS).A prospective, double-blind, placebo-controlled, randomized, parallel, multicenter pilot clinical trial.A total of 51 patients with sepsis-induced ARDS were entered into the study within 18 hours of developing sepsis or sepsis syndrome.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.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.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.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.

Full Text

Duke Authors

Cited Authors

  • Weg, JG; Balk, RA; Tharratt, RS; Jenkinson, SG; Shah, JB; Zaccardelli, D; Horton, J; Pattishall, EN

Published Date

  • November 1994

Published In

Volume / Issue

  • 272 / 18

Start / End Page

  • 1433 - 1438

PubMed ID

  • 7933425

Electronic International Standard Serial Number (EISSN)

  • 1538-3598

International Standard Serial Number (ISSN)

  • 0098-7484

Digital Object Identifier (DOI)

  • 10.1001/jama.1994.03520180057035

Language

  • eng