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Body Composition Monitor in Hemodialysis Patients

Primary Purpose

End Stage Renal Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
control of ultrafiltration
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring body composition, blood pressure, hemodialysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sejoong KimRecruiting

Outcomes

Primary Outcome Measures

blood pressure
Systolic blood pressure, number of anti-hypertensive agents hypotensive episode

Secondary Outcome Measures

biomarkers
C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF

Full Information

First Posted
April 9, 2010
Last Updated
April 13, 2010
Sponsor
Gachon University Gil Medical Center
Collaborators
Seoul National University Hospital, Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01103167
Brief Title
Body Composition Monitor in Hemodialysis Patients
Official Title
The Association Between Body Composition and Biomarkers in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Gachon University Gil Medical Center
Collaborators
Seoul National University Hospital, Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
body composition, blood pressure, hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
control of ultrafiltration
Intervention Description
During the interventional period, dry weight of patients will be adjusted according to the results of body composition.
Primary Outcome Measure Information:
Title
blood pressure
Description
Systolic blood pressure, number of anti-hypertensive agents hypotensive episode
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
biomarkers
Description
C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF
Time Frame
up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sejoong Kim, MD, PhD
Phone
82-32-460-8305
Email
imsejoong@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Kwon Wook Joo, MD, PhD
Phone
82-2-2072-1964
Email
junephro@paran.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sejoong Kim, MD, PhD
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sejoong Kim
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sejoong Kim, MD, PhD
Phone
82-32-460-8305
Email
imsejoong@hanmail.net
First Name & Middle Initial & Last Name & Degree
Kwon Wook Joo, MD, PhD
Phone
82-2-2072-1964
Email
junephro@paran.com
First Name & Middle Initial & Last Name & Degree
Kwon Wook Joo, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ho Jun Chin, MD, PhD

12. IPD Sharing Statement

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Body Composition Monitor in Hemodialysis Patients

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