Randomized Trial of Model Predictive Control for Improved Anemia Management

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Abstract
Background and objectives: Variable hemoglobin (Hb) response to erythropoiesis stimulating agents may result in adverse outcomes. The utility of model predictive control for drug dosing was previously demonstrated. Design, setting, participants, & measurements: This was a double-blinded, randomized, controlled trial to test model predictive control for dosing erythropoietin in ESRD patients. The trial included 60 hemodialysis patients who were randomized into a treatment arm (30 subjects) that received erythropoietin doses on the basis of the computer recommendations or a control arm (30 subjects) that received erythropoietin doses on the basis of recommendations from a standard anemia management protocol (control). The subjects were followed for 8 months, and the proportions of measured Hb within the target of 11 to 12 g/dl and outside 9 to 13 g/dl were measured. Variability of the Hb level was measured by the absolute difference between the achieved Hb and the target Hb of 11.5 g/dl as well as the area under the Hb curve. Results: Model predictive control resulted in 15 observations >13 or P = 0.051), produced a mean absolute difference between achieved Hb and 11.5 g/dl of 1.18 ± 0.18 g/dl (P < 0.001 difference in variance), and an area under the Hb curve of 3.38 ± 2.69 (P = 0.025 difference in variance). Conclusions: Model predictive control of erythropoietin administration improves anemia management.

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