Intelligent Control Approach to Anemia Management

University of Louisville62 enrolled

Overview

First clinical evaluation of "Smart Anemia Manager" algorithm.

The purpose of this single-center study is to test whether "Smart Anemia Manager" algorithm improves Hemoglobin stability compared to standard Anemia Management Protocol. Study site: Kidney Disease Program dialysis facility, University of Louisville, Louisville, KY.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

End-Stage Renal Disease

Interventions

ESA Dose Adjustment per standard Anemia Management ProtocolOTHER

Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility

ESA Dose Adjustment per "Smart Anemia Manager" AlgorithmOTHER

Amount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by "Smart Anemia Manager" algorithm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. ages 18 to 80, 2. receiving dialysis treatment, 3. receiving or expected to receive ESA treatment, 4. adequacy of dialysis Kt/V \>= 1.2, 5. adequate iron stores (Ferritin \> 200 ng/mL, TSat \> 20%). Exclusion criteria: 1. life expectancy less than 12 months, 2. frequent uncontrolled blood loss, 3. frequent dialyzer clotting, 4. frequent access related problems, 5. active infections, 6. severe cardiac disability, 7. coronary bypass within three months prior to the study 8. documented resistance to ESA 9. bone marrow suppression due to HIV, leukemia, or pharmacologic agents.

Locations (1)

University of Louisville Kidney Disease Program

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Percent Hb 10-12 g/dL

Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.

Time frame: 12 months

Secondary Outcomes

Percent Hb < 10 g/dL

Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.

Time frame: 12 months

Percent Hb > 12 g/dL

Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.

Time frame: 12 months

Mean Hb

Mean Hemoglobin concentration over follow-up period

Time frame: 12 months

ESA Dose

Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)

Time frame: 12 months

Data from ClinicalTrials.gov

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