[The effect of early goal-directed therapy on treatment of critical patients with severe sepsis/septic shock: a multi-center, prospective, randomized, controlled study].
OBJECTIVE
To investigate the effect of early goal-directed therapy (EGDT) on treatment of critical patients with severe sepsis/septic shock.


METHODS
A multi-center, prospective, randomized, controlled study was deployed. Totally 314 critical patients, from eight comprehensive hospitals in Zhejiang Province admitted during January, 2005 to January, 2008, suffering from severe sepsis/septic shock were randomized into conventional treatment group (n=151) and EGDT group (n=163), the patients of the former underwent fluid resuscitation guided by central venous pressure (CVP), systolic blood pressure (SBP) or mean artery pressure (MAP) and urinary output (UO), and the latter guided by CVP, SBP or MAP and UO plus central venous oxygen saturation (ScvO2). The patients were treated with fluid, blood transfusions and cardiac stimulants in a period of 6 hours after enrollment to reach the goal. The difference of 28-day survival rate and intensive care unit (ICU) mortality (primary end points), the length of ICU stay, the duration of mechanical ventilation, duration of antibiotics treatment, incidence of newly occurred infection, and severity scores (secondary end points) were compared between two groups.


RESULTS
Finally, a total of 303 patients were eligible to enter this study, with 157 patients in EGDT group and 146 patients in conventional treatment group. In comparison with conventional treatment group, the 28-day survival rate of EGDT group was increased by 17.7% (75.2% vs. 57.5%, P=0.001) and the ICU mortality of EGDT group was decreased by 15.7% (35.0% vs. 50.7%, P=0.035), the acute physiology and chronic health evaluation II (APACHEII) score (14.4+/-8.5 vs. 18.0+/-7.1, P=0.043), multiple organ dysfunction syndrome (MODS) score (5.8+/-3.1 vs. 8.9+/-3.7, P=0.014) and sepsis-related organ failure assessment (SOFA) score (5.6+/-2.9 vs. 10.4+/-3.7, P=0.001) were significantly decreased in EGDT group. Meanwhile, a significant shortening of duration of using antibiotics was also found [(13.4+/-10.0) days vs. (19.7+/-13.5) days, P=0.004], with a lowering of incidence of occurrence of new infection (37.6% vs. 53.4%, P=0.014). There were no differences in other parameters for secondary end points.


CONCLUSIONS
EGDT improves 28-day survival rate and clinical scores, and it shows beneficial effects on outcome of critical patients with severe sepsis/septic shock.
D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018805:Sepsis / Q000628:therapy*; D012772:Shock, Septic / Q000628:therapy*; D016896:Treatment Outcome