An evaluation of the hemodynamic effects of HA-1A human monoclonal antibody

D. H. Kett, A. A. Quartin, C. L. Sprung, C. J. Fisher, M. A. Pena, S. O. Heard, J. L. Zimmerman, T. E. Albertson, E. A. Panacek, L. A. Eidelman, R. M.H. Schein

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9 Scopus citations

Abstract

Objectives: We sought to determine whether there might be acute changes in hemodynamics attributable to HA-1A, a monoclonal antibody to endotoxin, in patients with presumed Gram-negative sepsis. Design: Post hoc analysis of a multicenter, randomized, double-blind, placebo-controlled study. Patients: A total of 543 patients with severe sepsis presumed to be caused by Gram- negative bacteria who were enrolled in a clinical trial to evaluate the efficacy and safety of HA-1A human monoclonal antibody. Interventions: Patients were randomly assigned to receive either 100 mg of HA-1A or placebo. Measurements and Main Results: Patients were grouped by the study drug, HA- 1A, or placebo, and the presence or absence of Gram-negative bacteremia. Hemodynamic variables were monitored from before, until 72 hrs after infusion of the study drug. For the entire study population (n = 543), no changes over time attributable to study drug were noted in the mean arterial pressure (p > .19), heart rate (p > .53) or the need for vasopressor administration (p > .62). One hundred ninety-seven patients underwent pulmonary artery catheterization and had hemodynamic data available from before the infusion of HA-1A or placebo until at least 12 hrs after infusion. Evaluating all 197 patients on an intent to treat basis demonstrated no significant differences over time in cardiac index (p > .15), oxygen delivery index (p > .43), or left ventricular stroke work index (p > .48) between patients who received HA-1A and those patients receiving placebo. Grouping patients by the presence of Gram-negative bacteremia and study drug received also failed to demonstrate any significant difference attributable to HA-1A in mean arterial pressure (p > .54), heart rate (p > .84), cardiac index (p > .13), oxygen delivery index (p > .05), or left ventricular stroke work index (p > .48) between populations. Conclusion: There is no apparent relationship between the administration of HA-1A, the presence of Gram-negative bacteremia, and hemodynamic profiles over the 72-hr study period.

Original languageEnglish (US)
Pages (from-to)1227-1234
Number of pages8
JournalCritical care medicine
Volume22
Issue number8
DOIs
StatePublished - Jan 1 1994

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Keywords

  • bacteremia
  • bacterial infection
  • blood pressure
  • cardiac output
  • endotoxins
  • Gram-negative bacteria
  • heart rate
  • hemodynamics
  • monoclonal antibody
  • shock, septic

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

Cite this

Kett, D. H., Quartin, A. A., Sprung, C. L., Fisher, C. J., Pena, M. A., Heard, S. O., Zimmerman, J. L., Albertson, T. E., Panacek, E. A., Eidelman, L. A., & Schein, R. M. H. (1994). An evaluation of the hemodynamic effects of HA-1A human monoclonal antibody. Critical care medicine, 22(8), 1227-1234. https://doi.org/10.1097/00003246-199408000-00005