ANTITHROMBIN-III (ATIII) REPLACEMENT THERAPY IN PATIENTS WITH SEPSIS AND OR POSTSURGICAL COMPLICATIONS - A CONTROLLED DOUBLE-BLIND, RANDOMIZED, MULTICENTER STUDY/

Background: ATIII is decreased in sepsis and/or shock and its baseline value correlates with mortality. The efficacy of ATIII therapy on mor tality was assessed in a selected group of patients admitted to the in tensive care unit (ICU) in a double-blind, randomized, multicenter stu dy. Methods: 120 patients admitted to the ICU with an ATIII concentrat ion < 70% were randomized to receive ATIII (total dose 24 000 units) o r placebo treatment for 5 days; 56 patients had septic shock. Results: ATIII concentrations in the treated group remained constant throughou t the treatment period (range 97-102%). The Kaplan-Meier analysis show ed no difference in overall survival between the two groups: 50 and 46 % for ATIII and placebo, respectively. Septic shock and hemodynamic su pport were unbalanced in the two groups at admission. Therefore the Co x analysis was carried out after adjusting for these two variables. Tr eatment with ATIII decreases the risk of death with an odds ratio (OR) of 0.56. Of the covariates analyzed, septic shock and the baseline mu ltiple organ failure score were negatively associated with survival an d plasma activity level was positively associated with survival with a n OR of 0.97 for each 1% increase in the ATIII plasma concentration at baseline. Conclusions: The results of ATIII treatment in this populat ion of patients suggests that replacement therapy reduces mortality in the subgroup of septic shock patients only.