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 mortality was assessed in a selected group of patients admitted to the intensive care unit (ICU) in a double-blind, randomized, multicenter study.


METHODS
120 patients admitted to the ICU with an ATIII concentration < 70% were randomized to receive ATIII (total dose 24000 units) or placebo treatment for 5 days; 56 patients had septic shock.


RESULTS
ATIII concentrations in the treated group remained constant throughout the treatment period (range 97-102%). The Kaplan-Meier analysis showed no difference in overall survival between the two groups: 50 and 46% for ATIII and placebo, respectively. Septic shock and hemodynamic support were unbalanced in the two groups at admission. Therefore the Cox analysis was carried out after adjusting for these two variables. Treatment with ATIII decreases the risk of death with an odds ratio (OR) of 0.56. Of the covariates analyzed, septic shock and the baseline multiple organ failure score were negatively associated with survival and plasma activity level was positively associated with survival with an OR of 0.97 for each 1% increase in the ATIII plasma concentration at baseline.


CONCLUSIONS
The results of ATIII treatment in this population of patients suggests that replacement therapy reduces mortality in the subgroup of septic shock patients only.
Baudo
F
F
Department of Hematology, Ospedale Niguarda, Milano, Italy. MD9821@mclink.it
Caimi
T M
TM
de Cataldo
F
F
Ravizza
A
A
Arlati
S
S
Casella
G
G
Carugo
D
D
Palareti
G
G
Legnani
C
C
Ridolfi
L
L
Rossi
R
R
D'Angelo
A
A
Crippa
L
L
Giudici
D
D
Gallioli
G
G
Wolfler
A
A
Calori
G
G
D018806:APACHE; D000368:Aged; D000990:Antithrombin III / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009102:Multiple Organ Failure / Q000209:etiology; D016017:Odds Ratio; D011183:Postoperative Complications / Q000188:drug therapy* / Q000401:mortality; D016016:Proportional Hazards Models; D018805:Sepsis / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D015842:Serine Proteinase Inhibitors / Q000172:deficiency* / Q000627:therapeutic use*; D016019:Survival Analysis
D015842:Serine Proteinase Inhibitors; D000990:Antithrombin III