HA-1A in septic patients with ARDS: Results from the pivotal trial

L. M. Bigatello, R. E. Greene, C. L. Sprung, Edward 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

Research output: Contribution to journalArticle

16 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)328-334
Number of pages7
JournalIntensive Care Medicine
Volume20
Issue number5
DOIs
StatePublished - May 1994
Externally publishedYes

Keywords

  • Adult respiratory distress syndrome
  • Anti-endotoxin monoclonal antibodies
  • HA-1A
  • Sepsis

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

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    Bigatello, L. M., Greene, R. E., Sprung, C. L., Panacek, E. A., Straube, R. C., Zimmerman, J. L., Maunder, R. J., Lanken, P. N., Pile-Spellmann, E., Stanek, K. S., Zaslavsky, A., & Zapol, W. M. (1994). HA-1A in septic patients with ARDS: Results from the pivotal trial. Intensive Care Medicine, 20(5), 328-334. https://doi.org/10.1007/BF01720904