Effect of the antiendotoxic agent, taurolidine, in the treatment of sepsis syndrome: a placebo-controlled, double-blind trial.
OBJECTIVE
To assess the benefit gained from administration of the antiendotoxic drug, taurolidine, on outcome in critically ill patients with sepsis syndrome.


METHODS
A prospective, randomized, double-blind trial.


METHODS
The general intensive therapy unit in a university teaching hospital.


METHODS
One hundred patients admitted with sepsis syndrome over a 2-yr period.


METHODS
Patients were randomized to receive the amino-acid derivative, taurolidine, or an identically presented placebo.


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%.


CONCLUSIONS
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.
Willatts
S M
SM
Intensive Therapy Unit, Bristol Royal Infirmary, UK.
Radford
S
S
Leitermann
M
M
D018806:APACHE; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018746:Systemic Inflammatory Response Syndrome / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D013654:Taurine / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D013829:Thiadiazines / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D013829:Thiadiazines; D013654:Taurine; C012566:taurolidine