Renal Replacement Therapy
Conditions
Brief summary
Prospective, real-time observational study of hemodialysis patients treated with erythropoiesis-stimulating agents (ESA) to currently recommended Hgb targets. Subjects will be evaluated dynamically for their blood viscosity status at the beginning and end of the dialysis treatment, and followed prospectively to assess outcomes. Blood specimens will be collected via the subject's hemodialysis port pre- and post-hemodialysis per study assessment visit. Blood will be analyzed at a designated laboratory facility for viscosity over a comprehensive range of shear rates and tested for intradialytic surges in blood viscosity. Subjects will be followed for 48 weeks.
Interventions
None listed
Sponsors
ProMetrics, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years old * On hemodialysis \> 3 months * On ESA treatment \> 3 months * Mean Hgb 11 g/dL - 12 g/dL (based on at least 3 Hgb results during the previous 8 weeks) * Latest Hgb 10.5 g/dL - 12.5 g/dL (measured within 1 week of study)
Exclusion criteria
* Inability or unwillingness to provide informed consent * Large variability in interdialytic weight gain (\>2 kg difference between low and high weight gain over last month) * More than 1 missed dialysis treatments in past month * Recent bleeding * Blood transfusion within 1 month * Hematologic disease other than anemia * Active inflammatory disease * Active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular mortality | One year |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality | One year |
| Vascular access thrombosis | One year |
Outcome results
None listed