Evaluation of drotrecogin alpha use in a Belgian university hospital.

OBJECTIVE: Sepsis remains a major cause of mortality in ICU patients, despite advances in therapy. Drotrecogin alpha (Drot AA), a recombinant human activated protein C with anti-inflammatory and anticoagulant properties, has proven to be successful in patients with at least one organ failure. Our goal was to evaluate the data in patients with sepsis and at least two organ dysfunctions in a large university hospital in Belgium.

SETTING: The study was conducted at the medical and surgical intensive care units of the 1850-bed university hospital of Leuven, Belgium.

METHODS: We retrospectively evaluated the use of Drot AA during a 2.5 year period. At baseline patients' demographics, type of infection, APACHE II (acute physiology and chronic health evaluation), SOFA (sequential organ failure assessment), DIC (diffuse intravascular coagulation) score and number of organ failures were obtained. Overall hospital mortality was defined as primary outcome measure. Special attention was paid to bleeding, the main side effect of Drot AA.

MAIN OUTCOME MEASURE: Evalution of hospital and ICU mortality in patients treated with Drot AA for severe sepsis.

RESULTS: Drot AA was administered to 23 patients with sepsis and at least 2 organ dysfunctions; all patients started treatment within 24 h of onset of the second organ failure. Mean age was 59 years. Mean number of organ failures was 3. Overall hospital mortality rate was 47.8%. A 28-day mortality of 26% was found, comparable with the 28-day mortality rate of the PROWESS trial. Bleeding, requiring more than 3 units of blood, occurred in 1 patient. Although underlying co-morbidity was more pronounced in survivors, non-survivors had a slightly higher median APACHE II, higher SOFA score and higher DIC score. However, the number of organ failures was identical in both groups.

CONCLUSIONS: Overall hospital mortality rate was similar as observed in the Belgian Registry and 28-day mortality was equal to the results of the PROWESS study. Due to the limited number of patients, it is not clear if patients should be selected based on APACHE II, DIC or number of organ failures. However, selection based on number of organ failures is more appropriate due to intrinsic problems of the APACHE II score.