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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Replacement Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

End-stage renal disease

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ProMetrics

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

PMID: 19670184 (View on PubMed)

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.