American journal of surgery
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Review
Identifying patients with severe sepsis who should not be treated with drotrecogin alfa (activated).
Historically, clinical trials evaluating treatment of patients with severe sepsis have failed to show a reduction of mortality. However, retrospective analyses of some of these trials showed benefits in certain patient subgroups. ⋯ Appropriate patient selection will be a key factor in the use of this newly approved therapeutic agent to treat severe sepsis. A review of the exclusion criteria used in the PROWESS trial should provide clinicians with a way of differentiating those patients in the critical care setting who will benefit most from treatment with drotrecogin alfa (activated) from those who should not be treated.
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An analysis of risks and benefits is an important component of patient care. Drotrecogin alfa (activated), the first approved cogin (a class of recombinant human coagulation inhibitors), provides a clear example of a treatment that requires a careful risk-benefit analysis. ⋯ However, the drug is a natural antithrombotic that can increase the risk of bleeding in recipients. We will discuss bleeding and other potential risks associated with drotrecogin alfa (activated) treatment, as well as the survival benefits seen with the use of this therapy in patients with severe sepsis.
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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.