Randomized trial of model predictive control for improved anemia management

Clin J Am Soc Nephrol. 2010 May;5(5):814-20. doi: 10.2215/CJN.07181009. Epub 2010 Feb 25.

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 <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.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Aged
  • Algorithms
  • Anemia / blood
  • Anemia / drug therapy*
  • Anemia / etiology
  • Biomarkers / blood
  • Clinical Protocols
  • Double-Blind Method
  • Drug Dosage Calculations*
  • Erythropoietin / administration & dosage*
  • Female
  • Hematinics / administration & dosage*
  • Hemoglobins / metabolism*
  • Humans
  • Kidney Failure, Chronic / blood
  • Kidney Failure, Chronic / complications
  • Kidney Failure, Chronic / therapy*
  • Male
  • Middle Aged
  • Models, Biological*
  • Nurse Practitioners
  • Renal Dialysis* / adverse effects
  • Time Factors
  • Treatment Outcome

Substances

  • Biomarkers
  • Hematinics
  • Hemoglobins
  • Erythropoietin