OBJECTIVE: To assess the benefit gained from administration of the antiendotoxic drug, taurolidine, on outcome in critically ill patients with sepsis syndrome. DESIGN: A prospective, randomized, double-blind trial. SETTING: The general intensive therapy unit in a university teaching hospital. PATIENTS: One hundred patients admitted with sepsis syndrome over a 2-yr period. INTERVENTIONS: Patients were randomized to receive the amino-acid derivative, taurolidine, or an identically presented placebo. MEASUREMENTS AND MAIN RESULTS: Acute Physiology and Chronic Health Evaluation II (APACHE II), sepsis, and organ failure scores were measured daily. Blood for culture and endotoxin assay (using the limulus amoebocyte lysate assay) was sampled every 12 hrs for up to 5 days. Hemodynamic variables were recorded every 4 hrs. Forty-nine patients received taurolidine and 51 patients received placebo. There was no difference in APACHE II score, Sepsis Score, or presence of infections between the groups. The frequency of Gram-negative bacteremia was low at 12%. There was no difference in endotoxin activity, clinical or bacteriologic outcome, resolution of organ failure, or mortality rate between groups. Predicted risk of death for patients receiving taurolidine was 45%, and the actual mortality rate was 44%. In the group that received placebo, the predicted mortality rate was 38% and the actual mortality rate was 39%. CONCLUSION:Taurolidine had no beneficial therapeutic effect on the outcome of patients admitted to the intensive therapy unit with sepsis syndrome, using clinical, bacteriologic outcomes, progression of endotoxemia, resolution of organ failure, and 28-day mortality rate as end points.
RCT Entities:
OBJECTIVE: To assess the benefit gained from administration of the antiendotoxic drug, taurolidine, on outcome in critically illpatients with sepsis syndrome. DESIGN: A prospective, randomized, double-blind trial. SETTING: The general intensive therapy unit in a university teaching hospital. PATIENTS: One hundred patients admitted with sepsis syndrome over a 2-yr period. INTERVENTIONS:Patients were randomized to receive the amino-acid derivative, taurolidine, or an identically presented placebo. MEASUREMENTS AND MAIN RESULTS: Acute Physiology and Chronic Health Evaluation II (APACHE II), sepsis, and organ failure scores were measured daily. Blood for culture and endotoxin assay (using the limulus amoebocyte lysate assay) was sampled every 12 hrs for up to 5 days. Hemodynamic variables were recorded every 4 hrs. Forty-nine patients received taurolidine and 51 patients received placebo. There was no difference in APACHE II score, Sepsis Score, or presence of infections between the groups. The frequency of Gram-negative bacteremia was low at 12%. There was no difference in endotoxin activity, clinical or bacteriologic outcome, resolution of organ failure, or mortality rate between groups. Predicted risk of death for patients receiving taurolidine was 45%, and the actual mortality rate was 44%. In the group that received placebo, the predicted mortality rate was 38% and the actual mortality rate was 39%. CONCLUSION:Taurolidine had no beneficial therapeutic effect on the outcome of patients admitted to the intensive therapy unit with sepsis syndrome, using clinical, bacteriologic outcomes, progression of endotoxemia, resolution of organ failure, and 28-day mortality rate as end points.
Authors: C Torres-Viera; C Thauvin-Eliopoulos; M Souli; P DeGirolami; M G Farris; C B Wennersten; R D Sofia; G M Eliopoulos Journal: Antimicrob Agents Chemother Date: 2000-06 Impact factor: 5.191