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

April 9, 2010
April 13, 2010
April 2010
October 2010   (final data collection date for primary outcome measure)
blood pressure [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]
Systolic blood pressure, number of anti-hypertensive agents hypotensive episode
Same as current
Complete list of historical versions of study NCT01103167 on ClinicalTrials.gov Archive Site
biomarkers [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
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
Both
18 Years to 80 Years
No
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
Korea, Republic of
 
NCT01103167
korea_bcm_hd
No
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