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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
ProMetrics, Inc.
ClinicalTrials.gov Identifier:
NCT01023893
First received: December 1, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition
Renal Replacement Therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Diagnostic Evaluation Study of Blood Viscosity, End-Stage Renal Disease, And Mortality

Resource links provided by NLM:


Further study details as provided by ProMetrics, Inc.:

Primary Outcome Measures:
  • Cardiovascular mortality [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Vascular access thrombosis [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: November 2009
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
End-stage renal disease

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Dialysis clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Daniel Cho, VP Lab Services, ProMetrics
ClinicalTrials.gov Identifier: NCT01023893     History of Changes
Other Study ID Numbers: PRO-0062-201
Study First Received: December 1, 2009
Last Updated: December 1, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on October 19, 2014