ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01023893
Recruitment Status : Unknown
Verified December 2009 by ProMetrics, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Sponsor:
Information provided by:
ProMetrics, Inc.

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
Renal Replacement Therapy

Study Type : Observational
Estimated 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 : November 2009
Estimated Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
End-stage renal disease



Primary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: One year ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: One year ]
  2. Vascular access thrombosis [ Time Frame: One year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Publications:
Responsible Party: Daniel Cho, VP Lab Services, ProMetrics
ClinicalTrials.gov Identifier: NCT01023893     History of Changes
Other Study ID Numbers: PRO-0062-201
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009

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