Intelligent Control Approach to Anemia Management

Not Applicable

Completed

• Conditions: End-Stage Renal Disease
• Interventions: Other: ESA Dose Adjustment per "Smart Anemia Manager" Algorithm; Other: ESA Dose Adjustment per standard Anemia Management Protocol

• Registration Number: NCT00572533
• Lead Sponsor: University of Louisville

Brief Summary

First clinical evaluation of "Smart Anemia Manager" algorithm.

Detailed Description

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 Timeline

• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-11
• Study First Posted: 2007-12-13
• Study Start: 2011-04
• Primary Completion: 2012-04
• Study Completion: 2012-08
• Results First Submitted: 2012-10-15
• Results First Submitted QC: 2012-12-19
• Results First Posted: 2012-12-20
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-15
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	ESA Dose Adjustment per "Smart Anemia Manager" Algorithm	ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Control	ESA Dose Adjustment per standard Anemia Management Protocol	ESA Dose Adjustment per standard Anemia Management Protocol

Primary Outcome Measures

Name	Time	Method
Percent Hb 10-12 g/dL	12 months	Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.

Secondary Outcome Measures

Name	Time	Method
ESA Dose	12 months	Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)
Percent Hb < 10 g/dL	12 months	Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.
Percent Hb > 12 g/dL	12 months	Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.
Mean Hb	12 months	Mean Hemoglobin concentration over follow-up period

Trial Locations

Locations (1)

University of Louisville Kidney Disease Program; 🇺🇸 Louisville, Kentucky, United States