Randomized trial of model predictive control for improved anemia management.

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 <9 g/dl (outliers), a mean absolute difference between achieved Hb and 11.5 g/dl of 0.98 +/- 0.08 g/dl, and an area under the Hb curve of 2.86 +/- 1.46. The control group algorithm resulted in 30 Hb outliers (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.