Try our beta test site

Body Composition Monitor in Hemodialysis Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Gachon University Gil Medical Center.
Recruitment status was:  Recruiting
Seoul National University Hospital
Seoul National University Bundang Hospital
Information provided by:
Gachon University Gil Medical Center Identifier:
First received: April 9, 2010
Last updated: April 13, 2010
Last verified: April 2010

Control of volume status is a pivotal issue in haemodialysis therapy. Objective and practical management for maintaining normovolemia is needed.

The investigators hypothesized that intervention of volume status with the body composition monitor (BCM) may improved hemodynamic parameters and biomarkers in hemodialysis patients.

Condition Intervention Phase
End Stage Renal Disease
Behavioral: control of ultrafiltration
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Association Between Body Composition and Biomarkers in Hemodialysis Patients

Resource links provided by NLM:

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • blood pressure [ Time Frame: up to 16 weeks ]
    Systolic blood pressure, number of anti-hypertensive agents hypotensive episode

Secondary Outcome Measures:
  • biomarkers [ Time Frame: up to 16 weeks ]
    C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF

Estimated Enrollment: 160
Study Start Date: April 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: control of ultrafiltration
    During the interventional period, dry weight of patients will be adjusted according to the results of body composition.
Detailed Description:

The investigators will assess BCM in enrolled hemodialysis patients by 4 weeks for 16 weeks During the former 8-week intervention period, The investigators will adjust patients' volume status according to the results of BCM.

During the latter 8-week observational period, The investigators will evaluate the changes of patients' hemodynamic parameters and biomarkers.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 6-month or more stable hemodialysis patients
  • 18 years or more
  • less than 5% of changes of dry weight for last 3 months

Exclusion Criteria:

  • pregnancy
  • active malignancy
  • cardiac pacemaker or defibrillator
  • history of extremity amputation
  • active infectious disease within 3 months
  • admission history for complication related to hemodialysis within 3 months
  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.

Please refer to this study by its identifier: NCT01103167

Korea, Republic of
Sejoong Kim
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
Seoul National University Hospital
Seoul National University Bundang Hospital
Principal Investigator: Sejoong Kim, MD, PhD Gachon University Gil Medical Center
  More Information

Responsible Party: Gachon University Gil Medical Center IRB, Gachon University Gil Medical Center Identifier: NCT01103167     History of Changes
Other Study ID Numbers: korea_bcm_hd 
Study First Received: April 9, 2010
Last Updated: April 13, 2010

Keywords provided by Gachon University Gil Medical Center:
body composition
blood pressure

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases processed this record on February 20, 2017