Bioimpedance Analysis for Hemodialysis

Not Applicable

Recruiting

• Conditions: Hemodialysis Complication
• Interventions: Device: Control; Device: Bioimpedance

• Registration Number: NCT06573567
• Lead Sponsor: Cishan Hospital, Ministry of Health and Welfare

Brief 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.

Study Timeline

• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-27
• Study Start: 2024-09-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-18
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-10-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Bioimpedance analysis done, but the results will be masked to the participants, care providers and outcome evaluators
Bioimpedance	Bioimpedance	Use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	From first bioimpedance analysis done to 1 year later	A composite of myocardial infarction, stroke and all-cause mortality

Secondary Outcome Measures

Name	Time	Method
The number of hemodialysis sessions with intradialytic cramps or postdialytic cramps	From first bioimpedance analysis done to 1 year later	Cramps during hemodialysis or later in the hemodialysis day, excluding those who experience cramps on non-hemodialysis day; cramps in both extremities and abdomen are counted
The number of hemodialysis sessions with pitting edema	From first bioimpedance analysis done to 1 year later	Pitting edema is defined as grade 1 or more
The number of hemodialysis sessions with intradialytic hypotension	From first bioimpedance analysis done to 1 year later	During hemodialysis, systolic blood pressures (SBP) drop to \<90mmHg, excluding those with baseline SBP \<90mmHg
The number of hemodialysis sessions with lung edema	From first bioimpedance analysis done to 1 year later	Lung edema is defined as either of the followings: 1. Crackles in lungs, excluding those with overt history or signs of other diseases that cause crackles, such as pneumonia, atelectasis or pleural disease; 2. Perihilar or interstitial pattern of infiltrations on chest X ray
The number of hemodialysis sessions with non-function of arteriovenous shunt	From first bioimpedance analysis done to 1 year later	Non-function means absence of thrill or bruit of the shunt, and/or needle could not be placed with adequate blood flow for dialysis; both arteriovenous fistula and graft are considered in this outcome

Trial Locations

Locations (1)

Cishan Hospital, MOHW, Taiwan; 🇨🇳 Kaohsiung, Taiwan