Body Composition Monitor in Hemodialysis Patients
- Conditions
- End Stage Renal Disease
- Registration Number
- NCT01103167
- Lead Sponsor
- Gachon University Gil Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- 6-month or more stable hemodialysis patients
- 18 years or more
- less than 5% of changes of dry weight for last 3 months
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method blood pressure up to 16 weeks Systolic blood pressure, number of anti-hypertensive agents hypotensive episode
- Secondary Outcome Measures
Name Time Method biomarkers up to 16 weeks C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF
Trial Locations
- Locations (1)
Sejoong Kim
🇰🇷Incheon, Korea, Republic of