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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01103167
First Posted: April 14, 2010
Last Update Posted: October 12, 2017
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.
Collaborators:
Seoul National University Hospital
Seoul National University Bundang Hospital
Information provided by:
Gachon University Gil Medical Center
April 9, 2010
April 14, 2010
October 12, 2017
April 2010
October 2010   (Final data collection date for primary outcome measure)
blood pressure [ Time Frame: up to 16 weeks ]
Systolic blood pressure, number of anti-hypertensive agents hypotensive episode
Same as current
No Changes Posted
biomarkers [ Time Frame: up to 16 weeks ]
C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF
Same as current
Not Provided
Not Provided
 
Body Composition Monitor in Hemodialysis Patients
The Association Between Body Composition and Biomarkers in Hemodialysis Patients

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.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
End Stage Renal Disease
Behavioral: control of ultrafiltration
During the interventional period, dry weight of patients will be adjusted according to the results of body composition.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
160
December 2010
October 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01103167
korea_bcm_hd
No
Not Provided
Not Provided
Gachon University Gil Medical Center IRB, Gachon University Gil Medical Center
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
Gachon University Gil Medical Center
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP