Bioimpedance Analysis for Hemodialysis

February 11, 2026 updated by: Han-ming Kuo, Cishan Hospital, Ministry of Health and Welfare

Target Weight Guided by Bioimpedance Analysis in Hemodialysis Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 842
        • Cishan Hospital, MOHW, Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bioimpedance
Use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month
Device: Bioimpedance
Experimental: use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month
Placebo Comparator: Control
Bioimpedance analysis done, but the results will be masked to the participants, care providers and outcome evaluators
Device: Control
Placebo Comparator: the measurements will also be obtained once per month, but not revealed to the participants and the care providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: From first bioimpedance analysis done to 1 year later
A composite of myocardial infarction, stroke and all-cause mortality
From first bioimpedance analysis done to 1 year later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of hemodialysis sessions with intradialytic hypotension
Time Frame: From first bioimpedance analysis done to 1 year later
During hemodialysis, systolic blood pressures (SBP) drop to <90mmHg, excluding those with baseline SBP <90mmHg
From first bioimpedance analysis done to 1 year later
The number of hemodialysis sessions with intradialytic cramps or postdialytic cramps
Time Frame: 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
From first bioimpedance analysis done to 1 year later
The number of hemodialysis sessions with pitting edema
Time Frame: From first bioimpedance analysis done to 1 year later
Pitting edema is defined as grade 1 or more
From first bioimpedance analysis done to 1 year later
The number of hemodialysis sessions with lung edema
Time Frame: 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
From first bioimpedance analysis done to 1 year later
The number of hemodialysis sessions with non-function of arteriovenous shunt
Time Frame: 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
From first bioimpedance analysis done to 1 year later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cishan Hospital, Ministry of Health and Welfare

Investigators

  • Study Chair: Han-Ming Kuo, Master, Cishan Hospital, MOHW, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

February 11, 2026

Study Completion (Actual)

February 11, 2026

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Bioimpedance_hemodialysis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

IPD Sharing Time Frame

one year after the research published

IPD Sharing Access Criteria

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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