The Association Between Body Composition and Biomarkers in Hemodialysis Patients
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- blood pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
blood pressure
Time Frame: up to 16 weeks
Systolic blood pressure, number of anti-hypertensive agents hypotensive episode
Secondary Outcomes
- biomarkers(up to 16 weeks)