NCT06573567

Bioimpedance Analysis for Hemodialysis

Target Weight Guided by Bioimpedance Analysis in Hemodialysis Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Cishan Hospital, Ministry of Health and Welfare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if bioimpedance-guided fluid management can help decrease hemodialysis complications. The main questions it aims to answer are: Does bioimpedance-guided fluid management decrease major cardiovascular events? Does bioimpedance-guided fluid management decrease other hemodialysis complications? Participants will: Take bioimpedance analysis once per month Adjust dry weight according to the analysis as possible in active group Blind the analysis results to the doctor and the patient in the control group

Detailed description

The goal of this clinical trial is to learn if bioimpedance-guided fluid management can decrease major adverse cardiovascular events (MACE), symptoms during hemodialysis, or other important outcomes such as vascular access patency, fluid overload admissions, etc. in maintenance hemodialysis patients. The main questions it aims to answer are: Hypothesis 1: bioimpedance-guided fluid management decreases MACE Hypothesis 2: bioimpedance-guided fluid management decreases intradialytic hypotension, cramps and fatigue Hypothesis 3: bioimpedance-guided fluid management decreases need for urgent revascularization of vascular access for hemodialysis Participants in the control group will decide their target weight according to physician's suggestion and the patient's preference, according to symptoms that are thought related to fluid status aberrancy (for example, edema, crackles for fluid overload, and cramps, intradialytic hypotension, fatigue for fluid insufficiency, given no other acute illness accountable for the symptoms and intradialytic weight gain not exceeding 5% of previous weight) Participants in the active (bioimpedance) group will adjust their dry weight as those in the control group, if symptoms of fluid status aberrancy present. However, if no symptoms occur, they will receive adjustment according to measurements by bioimpedance analysis.

Conditions

• Hemodialysis Complication

Interventions

Type	Name	Description
DEVICE	Bioimpedance	Experimental: use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month
DEVICE	Control	Placebo Comparator: the measurements will also be obtained once per month, but not revealed to the participants and the care providers

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-02-11
• Completion: 2026-02-11
• First posted: 2024-08-27
• Last updated: 2026-02-13

Locations

1 site across 1 country: Taiwan