Blood Viscosity, End-Stage Renal Disease, And Mortality (BEAM-1)
- Conditions
- Renal Replacement Therapy
- Registration Number
- NCT01023893
- Lead Sponsor
- ProMetrics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cardiovascular mortality One year
- Secondary Outcome Measures
Name Time Method All-cause mortality One year Vascular access thrombosis One year