American journal of surgery
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Selecting patients for drotrecogin alfa (activated) (Xigris; Eli Lilly and Company, Indianapolis, IN) therapy outside of a clinical trial setting requires knowledge of the rationale that led the Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) investigators to select the various entry criteria for the trial. Enrollment criteria for the study included a known or suspected infection, presence of at least 3 systemic inflammatory response syndrome (SIRS) criteria, and dysfunction of > or =1 organ or system. The infection criteria used in PROWESS were designed to be straightforward and were based on common clinical and radiological data. ⋯ Acute organ dysfunction, the diagnostic criterion for severe sepsis, was used to define the study population because it identifies patients at significant risk of death. Characteristics of drotrecogin alfa (activated)-treated patients, including infection, modified SIRS criteria, and organ dysfunction, were similar to those of the placebo group and the general sepsis population. Proper clinical judgment and use of the these inclusion criteria as a guide will help clinicians select and treat sepsis patients with drotrecogin alfa (activated).
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Critically ill patients encounter many obstacles, such as acute renal failure, that increases length of stay as well as hospital cost. Dialysis in these patients is often ineffective thereby prolonging the inevitable and significantly increasing the cost of care. A dialysis program that could improve patient care, potentially improve outcome and be "revenue neutral" would be ideal. ⋯ An in-house CRRT program improved patient care by providing dialysis in patients who normally would not tolerate the procedure. Although there was a loss of revenue, CRRT in the burn patients appeared "revenue neutral." Although not specifically studied in this review, based on published data, mortality rates in this population were lower than expected especially in critically ill burn patients.
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A number of management issues confront the clinician treating a critically ill patient with drotrecogin alfa (activated) (Xigris; Eli Lilly and Company, Indianapolis, IN), a compound documented to significantly reduce the risk of 28-day all-cause mortality in patients with severe sepsis. The management issues that will be discussed include differentiating drug effect from the hemostatic changes of sepsis, prevention and management of bleeding during drotrecogin alfa (activated) infusion, treatment considerations in the patient with thrombocytopenia or disseminated intravascular coagulation, thromboprophylaxis in drug-treated patients, and the use of drotrecogin alfa (activated) in patients requiring renal replacement therapy. Proper adherence to principles described in this article can facilitate patient management and reduce the risk of bleeding.