Aim: The aim of this study was the assessment of the efficacy of recombinant human activated protein C (rhAPC) in septic patients.
Methods: A continuous observational prospective study on ICU patients with severe sepsis and septic shock was carried out. Applying the inclusion criteria of a national trial on the use of rhAPC, 15 patients (12 males and 3 females) were enrolled, mean age was 65.9 (SD 9.6), APACHE II score was > or =25. The following variables were assessed on 7 time-points (T1-T7): overall SOFA score; organ-specific SOFA score; APACHE II score; PCR, APTT, INR, fibrinogen, platelet count. Wilcoxon's statistical test and Spearman's correlation test (rho coefficient) between the SOFA and APACHE II scores were used. Test results with a P value below 0.05 were deemed significant.
Results: A significant correlation was identified between the APACHE II and SOFA scores. No significant change was found in Friedman's test and the respiratory, haematological and hepatic SOFA score, whereas cardiovascular, renal and neurological SOFA scores showed a significant trend between the ranks at the 7 time-points (chi2=14; df=6; P=0.029). During rhAPC treatment Friedman's test showed significant changes of PCR values over the 7 time-points (chi2=19.2; df=6; P=0.02). Wilcoxon's test indicated a significant decrease in the values recorded during the T2-T6 period. On day 28, 12 of the 15 patients originally enrolled were still alive. Mortality rate was therefore 20% (CI 95%).
Conclusions: RhAPC is the first biological agent approved for the treatment of severe sepsis and septic shock. Our experience is confined to patients with severe sepsis and septic shock, and some severity indexes showed a modulation of the inflammatory processes and haemostatic balance, 2 factors which play a key role in the evolution of sepsis and organ dysfunction.