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.


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.
Kübler
Andrzej
A
Department of Anesthesiology and Intensive Care, Medical University of Wrocław, Wrocław, Poland.
Mayzner-Zawadzka
Ewa
E
Durek
Grazyna
G
Gaszyński
Wojciech
W
Karpel
Ewa
E
Mikaszewska-Sokolewicz
Małgorzata
M
Majak
Paweł
P
D018806:APACHE; D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005069:Evaluation Studies as Topic; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007362:Intensive Care Units / Q000706:statistics & numerical data; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011044:Poland / Q000453:epidemiology; D011159:Population Surveillance; D011486:Protein C / Q000009:adverse effects / Q000235:genetics / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000235:genetics / Q000627:therapeutic use; D012042:Registries; D012189:Retrospective Studies; D018805:Sepsis / Q000188:drug therapy* / Q000401:mortality; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D011486:Protein C; D011994:Recombinant Proteins; C421124:drotrecogin alfa activated