PURPOSE: This real-life registry was implemented to describe clinical characteristics of patients treated with drotrecogin alfa (activated) (DAA) in France and their mortality, especially in patients with pulmonary infection.
METHODS: This national multicenter observational study, proposed to intensive care units (ICUs) which used DAA, was conducted by data abstraction from hospital files of patients admitted to ICUs and treated by DAA. A set of retrospective data collected between January 1st, 2006 and April 30th 2009 was obtained. Statistical analysis was mainly descriptive.
RESULTS: 936 patients 62.2 (15.2) years old were enrolled in 65 ICUs (80% surgical or general, 20% medical) with 62% of male. The primary site of infection was the lung (55%), the abdomen (25%), and the urinary tract (10%). At time of DAA initiation, the mean SAPS II score was 60.3 (18.7), and the median number of organ failures (min;max) was 4 (2;7). For sepsis management before DAA administration, patients received antibiotics (99%), vasopressors (97%), mechanical ventilation (96%), corticosteroids (75%), heparin at prophylactic doses (45%), heparin at therapeutic doses (9%). For all the patients, the 31-day mortality rate (IC 95%) was 46% (42%-49%) and for patients with pulmonary infection the observed mortality rate was 50%. At the end of 31-day follow-up, 2% of patients had at least one severe bleeding event during treatment infusion and 3% after treatment infusion.
CONCLUSION: Patients treated by DAA in real-life had a particularly severe sepsis as shown by the SAPS II score of 60 and the high number of organ dysfunctions at time of infusion initiation and frequently had a pulmonary infection as the origin of sepsis. The 1-month observed mortality was lower than the predicted hospital mortality of 68% calculated using the SAPS II.
CLINICAL IMPLICATIONS: Patients with pulmonary infection had a higher mortality.
DISCLOSURE: Jean-louis Teboul, Employee Stephanie Tcherny is employee of Eli Lilly & Company.; No Product/Research Disclosure Information