Results of severe sepsis treatment program using recombinant human activated protein C in Poland.

BACKGROUND: Recombinant human activated protein C (drotrecogin alfa [activated]--DAA) demonstrated in Phase III controlled clinical studies significant reduction of mortality in patients with severe sepsis and high risk of death. The aim of the study was to assess the therapeutic efficacy of DAA in patients included in the National Severe Sepsis Register in Poland. MATERIAL/METHODS: The analysis included 3233 cases of severe sepsis reported between 04.2003 and 11.2005. 302 patients (9.3%) were treated with DAA. The clinical course of the disease in DAA and non-DAA treatment groups was compared. Logistic regression models for the effects of independent variables on the risk of death (dependent variable) were developed. RESULTS: In the patients treated with DAA, the relative risk of death was lower by 31% than in those who were not treated. In a multivariate logistic regression model, the use of DAA was, independently of the patient's age, severity of the clinical condition and type of organ dysfunction, the most significant mortality-reducing factor in severe sepsis. CONCLUSIONS: The use of DAA in the treatment of severe sepsis proved to be a very effective method of mortality reduction. Controlled nationwide surveillance program contributed to its effective utilization. The National Severe Sepsis Register proved to be a very useful instrument for assessment of the course of the disease and treatment efficacy.