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Completed

NCT Number: NCT06573567

Bioimpedance Analysis for Hemodialysis

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

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Key information

Conditions

Hemodialysis Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cishan Hospital, MOHW, Taiwan

Kaohsiung City, 842, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bioimpedance

Device

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

Control

Device

Placebo Comparator: the measurements will also be obtained once per month, but not revealed to the participants and the care providers

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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:

    • Crackles in lungs, excluding those with overt history or signs of other diseases that cause crackles, such as pneumonia, atelectasis or pleural disease
    • Perihilar or interstitial pattern of infiltrations on chest X ray

  5. 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

Sponsors and collaborators

Lead sponsor

Cishan Hospital, Ministry of Health and Welfare

Other

Registry information

Official study title

Target Weight Guided by Bioimpedance Analysis in Hemodialysis Patients

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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