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

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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.

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

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Placebos
Time and Motion Studies
Intratracheal Intubation
Survival
Therapeutics
Intravenous Injections
Respiratory Insufficiency
Survival Rate
Logistic Models
Monoclonal Antibodies
Injections
Mortality

Keywords

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

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

Cite this

Bigatello, L. M., Greene, R. E., Sprung, C. L., Panacek, E. A., Straube, R. C., Zimmerman, J. L., ... 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

HA-1A in septic patients with ARDS : Results from the pivotal trial. / Bigatello, L. M.; Greene, R. E.; Sprung, C. L.; Panacek, Edward A; Straube, R. C.; Zimmerman, J. L.; Maunder, R. J.; Lanken, P. N.; Pile-Spellmann, E.; Stanek, K. S.; Zaslavsky, A.; Zapol, W. M.

In: Intensive Care Medicine, Vol. 20, No. 5, 05.1994, p. 328-334.

Research output: Contribution to journalArticle

Bigatello, LM, Greene, RE, Sprung, CL, Panacek, EA, Straube, RC, Zimmerman, JL, Maunder, RJ, Lanken, PN, Pile-Spellmann, E, Stanek, KS, Zaslavsky, A & Zapol, WM 1994, 'HA-1A in septic patients with ARDS: Results from the pivotal trial', Intensive Care Medicine, vol. 20, no. 5, pp. 328-334. https://doi.org/10.1007/BF01720904
Bigatello LM, Greene RE, Sprung CL, Panacek EA, Straube RC, Zimmerman JL et al. HA-1A in septic patients with ARDS: Results from the pivotal trial. Intensive Care Medicine. 1994 May;20(5):328-334. https://doi.org/10.1007/BF01720904
Bigatello, L. M. ; Greene, R. E. ; Sprung, C. L. ; Panacek, Edward A ; Straube, R. C. ; Zimmerman, J. L. ; Maunder, R. J. ; Lanken, P. N. ; Pile-Spellmann, E. ; Stanek, K. S. ; Zaslavsky, A. ; Zapol, W. M. / HA-1A in septic patients with ARDS : Results from the pivotal trial. In: Intensive Care Medicine. 1994 ; Vol. 20, No. 5. pp. 328-334.
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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.",
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