An evaluation of the hemodynamic effects of HA-1A human monoclonal antibody.
Crit Care Med
; 22(8): 1227-34, 1994 Aug.
Article
em En
| MEDLINE
| ID: mdl-8045141
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. MEASUREMENT AND MAINRESULTS:
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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Infecções por Bactérias Gram-Negativas
/
Bacteriemia
/
Endotoxinas
/
Anticorpos Monoclonais
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Limite:
Humans
/
Middle aged
Idioma:
En
Revista:
Crit Care Med
Ano de publicação:
1994
Tipo de documento:
Article