HA-1A in septic patients with ARDS: Results from the pivotal trial |
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| Authors: | L. M. Bigatello R. E. Greene C. L. Sprung E. A. Panacek R. C. Straube J. L. Zimmerman R. J. Maunder P. N. Lanken E. Pile-Spellmann K. S. Stanek A. Zaslavsky W. M. Zapol |
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| Affiliation: | (1) Department of Anaesthesia at Massachusetts General Hospital, 02114 Boston, MA, USA;(2) Department of Radiology at Massachusetts General Hospital, 02114 Boston, MA, USA;(3) Department of Statistics of the Harvard Medical School at Massachusetts General Hospital, 02114 Boston, MA, USA;(4) Department of Medicine, University of Miami, Miami, FL, USA;(5) Hadassah Hebrew University Medical Center, Jerusalem, Israel;(6) Department of Medicine, Case Western Reserve University, Cleveland, OH, USA;(7) Research and Development Division, Centocor, Inc., Malvern, PA, USA;(8) Department of Medicine, Baylor College of Medicine, Houston, TX, USA;(9) Department of Medicine, University of Washington, Seattle, WA, USA;(10) Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA |
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| Abstract: | Objective To evaluate the effects of HA-1A, a human monoclonal antiendotoxin antibody, in septic patients with ARDS.Design Substudy of a multicenter, double-blinded, placebo-controlled trial of HA-1A in septic patients.Patients 63 septic patients with ARDS at the time of study entry.Intervention A single intravenous injection of HA-1A (100 mg) or placebo.Results A quantitative radiographic score, the PaO2/FIO2 ratio and an index of the severity of ARDS did not show a significant difference between the treatment and placebo groups at 3, 5 and 7 days after treatment. The duration of endotracheal intubation did not differ between the two groups. 15 of 30 HA-1A treated patients (50%) and 23 of 33 placebo-treated patients (69.7%) died within 28 days. The daily mortality was always lower in the HA-1A group, but this difference was not statistically significant at 28 days. The 28-day survival curves for the two treatment groups adjusted by covariate analysis were not significantly different (p=0.07). Using logistic regression, a significant independent effect of HA-1A treatment was detected upon the early survival rate at 7 days (p=0.03) but not at 14 and 28 days.Conclusion A single injection of HA-1A in septic patients with ARDS did not reverse acute respiratory failure or improve long-term survival.This study was supported by a grant from Centocor Inc., Malvern, PA, USA |
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| Keywords: | Adult respiratory distress syndrome Sepsis Anti-endotoxin monoclonal antibodies HA-1A |
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