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

Renal Replacement Therapy Clinical Trial

— BEAM-1  

Official title:

Clinical Diagnostic Evaluation Study of Blood Viscosity, End-Stage Renal Disease, And Mortality

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01023893
• Other study ID #: PRO-0062-201
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 1, 2009
• Last updated: December 1, 2009
• Start date: November 2009

Study information

• Verified date: December 2009
• Source: ProMetrics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Replacement Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ProMetrics, Inc.

References & Publications (2)

Lowe GD, Lee AJ, Rumley A, Price JF, Fowkes FG. Blood viscosity and risk of cardiovascular events: the Edinburgh Artery Study. Br J Haematol. 1997 Jan;96(1):168-73. — View Citation

Vaisman S, Kensey K, Cho YI. Effect of hemodialysis on whole blood viscosity. Int J Artif Organs. 2009 Jun;32(6):329-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular mortality		One year	No
Secondary	All-cause mortality		One year	No
Secondary	Vascular access thrombosis		One year	No