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

Sponsor
ProMetrics, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01023893
Collaborator
(none)
400
Enrollment

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Clinical Diagnostic Evaluation Study of Blood Viscosity, End-Stage Renal Disease, And Mortality
    Study Start Date :
    Nov 1, 2009
    Anticipated Primary Completion Date :
    Nov 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    End-stage renal disease

    Outcome Measures

    Primary Outcome Measures

    1. Cardiovascular mortality [One year]

    Secondary Outcome Measures

    1. All-cause mortality [One year]

    2. Vascular access thrombosis [One year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • ProMetrics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01023893
    Other Study ID Numbers:
    • PRO-0062-201
    First Posted:
    Dec 2, 2009
    Last Update Posted:
    Dec 2, 2009
    Last Verified:
    Dec 1, 2009
    Additional relevant MeSH terms:
    Kidney Failure, Chronic

    Study Results

    No Results Posted as of Dec 2, 2009