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Results of severe sepsis treatment program using recombinant human activated protein C in Poland
Andrzej Kübler1, Ewa Mayzner-Zawadzka, Grazyna Durek
1Department of Anesthesiology and Intensive Care, Medical University of Wrocław, Wrocław, Poland.
Insights
Recombinant human activated protein C (drotrecogin alfa [activated]--DAA) significantly reduced mortality in severe sepsis patients. This sepsis treatment was independently associated with lower death risk, demonstrating its efficacy.
Area of Science:
- Critical Care Medicine
- Pharmacology
- Epidemiology
Background:
- Recombinant human activated protein C (drotrecogin alfa [activated]--DAA) showed mortality reduction in severe sepsis patients in prior Phase III trials.
- The study aimed to evaluate DAA's therapeutic efficacy within Poland's National Severe Sepsis Register.
Purpose of the Study:
- To assess the efficacy of drotrecogin alfa [activated] (DAA) in reducing mortality among severe sepsis patients.
- To analyze treatment outcomes using data from the National Severe Sepsis Register in Poland.
Main Methods:
- Analysis of 3233 severe sepsis cases from April 2003 to November 2005.
- Comparison of clinical outcomes between 302 patients treated with DAA and those not receiving DAA.
- Development of logistic regression models to identify mortality risk factors.
Main Results:
- Patients treated with DAA exhibited a 31% lower relative risk of death compared to non-DAA treated patients.
- Multivariate analysis confirmed DAA as a significant independent factor in reducing severe sepsis mortality.
- DAA's benefit was observed irrespective of patient age, clinical condition severity, or organ dysfunction type.
Conclusions:
- Drotrecogin alfa [activated] (DAA) is a highly effective treatment for reducing mortality in severe sepsis.
- A nationwide surveillance program facilitated the effective use of DAA.
- The National Severe Sepsis Register proved valuable for evaluating disease progression and treatment effectiveness.
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.
