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

NCT01023893 | Unknown

• 1 other identifier: PRO-0062-201
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• Cardiovascular mortality

  One year

Secondary Outcomes (2)

• All-cause mortality

  One year

• Vascular access thrombosis

  One year

Study Arms (1)

End-stage renal disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dialysis clinic

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ProMetrics, Inc.: lead

Related Publications (2)

• Vaisman S, Kensey K, Cho YI. Effect of hemodialysis on whole blood viscosity. Int J Artif Organs. 2009 Jun;32(6):329-35. doi: 10.1177/039139880903200603.

  PMID: 19670184 BACKGROUND

• 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. doi: 10.1046/j.1365-2141.1997.8532481.x.

  PMID: 9012704 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Last Updated: December 2, 2009

Record last verified: 2009-12