Background Recombinant, activated factor VII(rFVIIa) decreases requirements for allogenic blood transfusion and chest re-exploration in cardiac surgical patients. Whether rFVIIa increases risk for postoperative adverse events is unclear. We tested whether rFVIIa administration was associated with increased mortality, neurologic and renal morbidity in cardiac surgical patients. Risk of thromboembolic complications and the dose-response of rFVIIa on mortality and morbidity was also evaluated. Methods Of 27,977 patients who had complex cardiac surgery, 164 patients(0.59%) received rFVIIa perioperatively. Using propensity-matching techniques, patients were matched to a maximum of 3 controls. Patients who received rFVIIa were compared with controls on risk of mortality, neurologic and renal morbidity and thromboembolic complications, including a composite of myocardial infarction, pulmonary embolism, and deep venous thrombosis. A corresponding “dose-response” analysis using multivariable logistic regression was also performed. Results Propensity techniques successfully matched 144 patients(88%) with 359 controls. Of patients who received rFVIIa, 40% experienced in-hospital mortality compared to 18% of controls(OR 2.82(1.64, 4.87);P<0.001). Furthermore, 31% of patients treated with rFVIIa vs 17% of controls experienced renal morbidity(OR 2.07(1.19, 3.62);P=0.002), however neurologic morbidity and thromboembolic complications were not different among groups. High-dose(>60mcg/kg) did not increase risk for mortality compared to treatment with low-dose rFVIIa(<60mcg/kg). Conclusion Administration of rFVIIa is associated with increased mortality and renal morbidity in cardiac surgery patients.
Clinical pharmacy services in the critical care setting have expanded dramatically and include assisting physicians in pharmacotherapy decision making, providing pharmacokinetic consultations, monitoring patients for drug efficacy and safety, providing drug information, and offering medical education to physicians, nurses, and patients. Measurable clinical effects of these services include reduced drug errors and adverse drug events, decreased morbidity and mortality rates, and a positive pharmacoeconomic impact by decreasing overall health care costs.
Background: The importance of near-normal blood glucose in the immediate postoperative period is generally accepted and is best achieved in the perioperative period with a constant intravenous (IV) infusion of insulin. This requires intensive nursing only achievable in an intensive care unit (ICU) setting. Glucose management after transfer to a regular nursing floor (RNF) has not been studied systematically. In August 2006, the Cleveland Clinic began using long-acting insulin glargine as the insulin infusion was terminated in the ICU. Methods: This prospective analysis examined all patients receiving IV insulin infusion after cardiothoracic surgery in a 1 month period. The analyses evaluated the safety and efficacy of a protocol using a transition to subcutaneous insulin glargine of 50% of the calculated 24 h requirement at the end of the ICU insulin infusion protocol in preparation for transfer to the RNF. Results: Only 1 patient in 99 developed hypoglycemia, and no patient suffered severe hypoglycemia (glucose < 40 mg/dl), while the majority (70%) had euglycemia (glucose between 70 and 150 mg/dl). Conclusions: This approach was both safe—as there was very little hypoglycemia (1 patient in 99)—and effective, as blood sugar was well controlled in most subjects. Efficacy for achieving euglycemia was 70%. Efficacy was likely reduced because of the upper limit of insulin glargine dosage imposed by some providers as a safety consideration. Although there was a physician option to override, the maximum protocol dose of 30 U was rarely exceeded, leading to inadequate dosing in some subjects who required high insulin infusion rates in the ICU.
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