Body Composition Monitor in Hemodialysis Patients

Gachon University Gil Medical Center

Status and phase: Unknown; Phase 4

Conditions: End Stage Renal Disease

Treatments: Behavioral: control of ultrafiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT01103167

korea_bcm_hd

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)