Bioimpedance Analysis for Hemodialysis

Cishan Hospital, Ministry of Health and Welfare

Status: Enrolling

Conditions: Hemodialysis Complication

Treatments: Device: Bioimpedance; Device: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06573567

Bioimpedance_hemodialysis

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has received hemodialysis >= 3 months
• Has at least 1 pair of intact same-side upper extremity and lower extremity

Exclusion criteria

• Pregnant
• With a cardiac pacemaker
• With metallic implants that may interfere with measurements (cardiac stents acceptable)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Bioimpedance

Experimental group

Description:

Use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month

Treatment:

Device: Bioimpedance

Control

Placebo Comparator group

Description:

Bioimpedance analysis done, but the results will be masked to the participants, care providers and outcome evaluators

Treatment:

Device: Control