Blood Viscosity, End-Stage Renal Disease, And Mortality (BEAM-1)

ProMetrics

Status: Unknown

Conditions: Renal Replacement Therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT01023893

PRO-0062-201

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

End-stage renal disease