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Body Composition Monitor in Hemodialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Gachon University Gil Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Seoul National University Hospital
Seoul National University Bundang Hospital
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01103167
First received: April 9, 2010
Last updated: April 13, 2010
Last verified: April 2010
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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

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


Secondary Outcome Measures:
  • biomarkers [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103167

Contacts
Contact: Sejoong Kim, MD, PhD 82-32-460-8305 imsejoong@hanmail.net
Contact: Kwon Wook Joo, MD, PhD 82-2-2072-1964 junephro@paran.com

Locations
Korea, Republic of
Sejoong Kim Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Sejoong Kim, MD, PhD     82-32-460-8305     imsejoong@hanmail.net    
Contact: Kwon Wook Joo, MD, PhD     82-2-2072-1964     junephro@paran.com    
Sub-Investigator: Kwon Wook Joo, MD, PhD            
Sub-Investigator: Ho Jun Chin, MD, PhD            
Sponsors and Collaborators
Gachon University Gil Medical Center
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Sejoong Kim, MD, PhD Gachon University Gil Medical Center
  More Information

No publications provided

Responsible Party: Gachon University Gil Medical Center IRB, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01103167     History of Changes
Other Study ID Numbers: korea_bcm_hd
Study First Received: April 9, 2010
Last Updated: April 13, 2010
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013