The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Anemia |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | July 2013 |
| End Date: | August 2014 |
| Contact: | Michael J Germain, MD |
| Email: | michael.germain@baystatehealth.org |
| Phone: | 413-733-9666 |
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
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.
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.
Inclusion Criteria:
- 18 years old or older
- Receiving hemodialysis in an out-patient dialysis unit
Exclusion Criteria:
- Not receiving EPOGEN as part of their standard medical care
- Patient refusal
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