Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron) protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain in target Objectives: 1. Decreased variability of Hgb 2. Increase the % of patients in target range c Increase in time that Hgb remains target range
Study Design One dialysis unit shift comprising up to 200 patients. Study participation will last for 12 months broken into 3 phases as described below. Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care. Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP. The individual AMP will be utilized weekly during the 9 months of Phase 2. The 3 objectives will be evaluated and updated weekly, Baseline to Year 1. All Epo dosing recommendations must be reviewed by the treating physician who can either accept or modify doses at his/her discretion based on clinical event that are not includes in the transmitted data such as bleeding, infection, and hospitalization.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care. Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP .
Chicopee Dialysis Center
Chicopee, Massachusetts, United States
Intraindividual Hemoglobin (Hgb) variability
Change in average intraindividual Hgb variability between control period and treatment periods.
Time frame: Evaluated and updated weekly for 52 weeks
Average hemoglobin levels
Change in average Hgb levels between control treatment periods, and change in interindividual Hgb variability between control treatment periods.
Time frame: Evaluated and updated weekly for 52 weeks
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