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Safety and Potential Efficacy of an Aerosolized Surfactant in Human Sepsis-Induced Adult Respiratory Distress Syndrome
John G. Weg, MD;
Robert A. Balk, MD;
R. Steven Tharratt, MD;
Stephen G. Jenkinson, MD;
Jagdip B. Shah, MD;
David Zaccardelli, PharmD;
John Horton;
Edward N. Pattishall, MD;
the Exosurf ARDS Sepsis Study Group;
Timothy E. Albertson, MD;
Edgar J. Caldwell, MD;
Stephen G. Jenkinson, MD;
Robert A. Balk, MD;
Neil R. MacIntyre, MD;
Anthony A. Meyer, MD;
John G. Weg, MD;
Anthony Killian, MD;
Spencer K. Koerner, MD;
Henry J. Silverman, MD;
Paul N. Lanken, MD;
Daniel P. Schuster, MD;
John H. Siegel, MD;
John A. Weigelt, MD;
James H. Williams, MD;
Warren R. Summer, MD;
Leo C. Roteilo, MD;
Steven G. Peters, MD;
Donald J. Scholten, MD;
Paul A. Kearney, MD;
H. David Reines, MD
JAMA. 1994;272(18):1433-1438.
Abstract
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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, mutlicenter 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 parameter 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.
(JAMA. 1994;272:1433-1438)
Author Affiliations
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From the Pulmonary and Critical Care Medicine Division, Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor (Dr Weg); the Department of Pulmonary and Critical Care Medicine, Rush-Presbyterian-St Luke's Medical Center, Chicago, Ill (Dr Balk); the Division of Pulmonary and Critical Care Medicine, University of California—Davis Medical Center, Sacramento (Dr Tharratt); the Pulmonary Disease Section, Audie L. Murphy Veterans Affairs Hospital, San Antonio, Tex (Dr Jenkinson); the Department of Anesthesiology, Medical College of Virginia, Richmond (Dr Shah); and the Clinical Research Division, Burroughs Wellcome Co, Research Triangle Park, NC (Drs Zaccardelli and Pattishall and Mr Horton).
University of California-Davis Medical Center, Sacramento; Maine Medical Center, Portland; Audie L. Murphy VA Hospital, San Antonio, Tex; Rush-Presbyterian-St Luke's Medical Center, Chicago, III; Duke University, Durham, NC; University of North Carolina, Chapel Hill; University of Michigan Medical Center, Ann Arbor; West Pennsylvania Hospital, Pittsburgh; Cedars Sinai Medical Center, Los Angeles, Calif; University of Maryland Hospital, Baltimore; University of Pennsylvania Hospital, Philadelphia; Washington University School of Medicine, St Louis, Mo; Maryland Institute of Emergency Medical Systems Services, University of Maryland, Baltimore; University of Texas, Southwestern Medical Center, Dallas; University of California-Irvine Medical Center, Orange; Louisiana State University School of Medicine, New Orleans; SUNY Health Science Center, Syracuse, NY; Mayo Clinic, Rochester, Minn; Butterworth Hospital, Grand Rapids, Mich; University of Kentucky Chandler Medical Center, Lexington; Medical College of Virginia, Richmond
Footnotes
A complete list of members of the Exosurf ARDS Sepsis Study Group appears at the end of this article.
Reprint requests to the Pulmonary and Critical Care Medicine Division, Department of Internal Medicine, University of Michigan Medical Center, Room B1H245-0026,1500 E Medical Center Dr, Ann Arbor, Ml 48109-0026 (Dr Weg).
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