Assessment of utilization and outcomes of drotrecogin alpha [activated] for critically ill patients with sepsis at a government acute care hospital: a retrospective study

ABSTRACT

Several quality improvement projects have documented the positive outcome of protocol-driven sepsis care. Drotrecogin Alpha Activated [DAA] [recombinant human activated protein C] has been advocated and used in the treatment of septic shock in suitable patients. The primary objective of this retrospective study was to evaluate the utilization of DAA guidelines at our institution, and the financial impact of inappropriate use of this agent due to any cause. The secondary objectives were to assess outcome in terms of mortality at 28-days and the incidence of serious bleeding events during the infusion. A retrospective analysis using electronic database for patients who received DAA from June 2008 until April 2011 was conducted at our 20-bed intensive care unit [ICU] at a government hospital as a part of continued Medication-Use Evaluation [MUE] process. Among the 41 patients who received DAA, the indication was appropriate for 32 [78%]. For those patients, the mean score for the Acute Physiology And Chronic Health Evaluation-II [APACHE II] was 27 +/- 4 and the mean number of dysfunctional organs was 3 +/- 0.5. The 28-day mortality was 56% [23/41]. Of the patients who died, 39% [9/23] had poor prognosis thus were not eligible for DAA. The APACHE II score was higher than 25 in 93% [38/41] of patients. The other 3 patients had an APACHE II score of less than 25 [7%]. Inappropriate use of DAA occurred in 8 [20%] and totaled 385 mg at a cost of $25755. The rate of serious bleeding during the infusion was 10% [4/41]. The results showed that DAA protocol was not strictly followed at our institution, which had a huge financial burden. Mortality and bleeding rates were higher than those reported by randomized clinical trials, but due to the study design, results need further validation