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AzTrials

Hemodialysis ComplicationNCT06573567

Bioimpedance Analysis for Hemodialysis

A study testing Bioimpedance in people with Hemodialysis Complication, run by Cishan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemodialysis Complication
What is being tested?
Bioimpedance
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteTaiwan
Study dates
1 Sep 2024to 11 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Cishan Hospital, MOHW, Taiwan

    Kaohsiung City, 842

Other trials in Taiwan

About this study

Official title: 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

Read the 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.

Being tested
Bioimpedance, Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioimpedanceDevice

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

  • ControlDevice

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

Study groups in NCT06573567
Study groupRoleWhat they receive
BioimpedanceExperimentalUse overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month
Receives: Device: Bioimpedance
ControlPlacebo comparatorBioimpedance analysis done, but the results will be masked to the participants, care providers and outcome evaluators
Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiovascular events

    A composite of myocardial infarction, stroke and all-cause mortality

    Measured: From first bioimpedance analysis done to 1 year later

Secondary outcomes (5)

  1. The number of hemodialysis sessions with intradialytic hypotension

    During hemodialysis, systolic blood pressures (SBP) drop to <90mmHg, excluding those with baseline SBP <90mmHg

    Measured: From first bioimpedance analysis done to 1 year later

  2. The number of hemodialysis sessions with intradialytic cramps or postdialytic cramps

    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

    Measured: From first bioimpedance analysis done to 1 year later

  3. The number of hemodialysis sessions with pitting edema

    Pitting edema is defined as grade 1 or more

    Measured: From first bioimpedance analysis done to 1 year later

  4. The number of hemodialysis sessions with lung edema

    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

    Measured: From first bioimpedance analysis done to 1 year later

  5. The number of hemodialysis sessions with non-function of arteriovenous shunt

    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

    Measured: From first bioimpedance analysis done to 1 year later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2024
  2. Study start1 Sep 2024
  3. Primary completion11 Feb 2026
  4. Study completion11 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06573567
Sponsor's protocol ID
Bioimpedance_hemodialysis
Status last verified
Feb 2026
First submitted
21 Aug 2024
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Liu L, Sun Y, Chen Y, Xu J, Yuan P, Shen Y, Lin S, Sun W, Ma Y, Ren J, Liu W, Lei J, Zuo L. The effect of BCM guided dry weight assessment on short-term survival in Chinese hemodialysis patients : Primary results of a randomized trial - BOdy COmposition MOnitor (BOCOMO) study. BMC Nephrol. 2020 Apr 15;21(1):135. doi: 10.1186/s12882-020-01793-x.

    PubMed 32295531

  • Onofriescu M, Mardare NG, Segall L, Voroneanu L, Cusai C, Hogas S, Ardeleanu S, Nistor I, Prisada OV, Sascau R, Covic A. Randomized trial of bioelectrical impedance analysis versus clinical criteria for guiding ultrafiltration in hemodialysis patients: effects on blood pressure, hydration status, and arterial stiffness. Int Urol Nephrol. 2012 Apr;44(2):583-91. doi: 10.1007/s11255-011-0022-y. Epub 2011 Jun 19.

    PubMed 21688195

  • Hur E, Usta M, Toz H, Asci G, Wabel P, Kahvecioglu S, Kayikcioglu M, Demirci MS, Ozkahya M, Duman S, Ok E. Effect of fluid management guided by bioimpedance spectroscopy on cardiovascular parameters in hemodialysis patients: a randomized controlled trial. Am J Kidney Dis. 2013 Jun;61(6):957-65. doi: 10.1053/j.ajkd.2012.12.017. Epub 2013 Feb 15.

    PubMed 23415416

  • Onofriescu M, Hogas S, Voroneanu L, Apetrii M, Nistor I, Kanbay M, Covic AC. Bioimpedance-guided fluid management in maintenance hemodialysis: a pilot randomized controlled trial. Am J Kidney Dis. 2014 Jul;64(1):111-8. doi: 10.1053/j.ajkd.2014.01.420. Epub 2014 Feb 28.

    PubMed 24583055

  • Huan-Sheng C, Yeong-Chang C, Ming-Hsing H, Fan-Lieh T, Chu-Cheng L, Tsai-Kun W, Hung-Ping C, Sze-Hung H, Hsien-Chang C, Chia-Chen L, Chun-Cheng H, Chun-Ting C, Hung-Hsiang L, Chun-Ju L, Paik-Seong L. Application of bioimpedance spectroscopy in Asian dialysis patients (ABISAD-III): a randomized controlled trial for clinical outcomes. Int Urol Nephrol. 2016 Nov;48(11):1897-1909. doi: 10.1007/s11255-016-1415-8. Epub 2016 Sep 12.

    PubMed 27620902

  • Patel HV, Annigeri RA, Kowdle PC, Rao BS, Seshadri R, Balasubramanian S, Vadamalai V. Bioimpedance Spectroscopy-Guided Ultrafiltration Normalizes Hydration and Reduces Intradialytic Adverse Events in Hemodialysis Patients. Indian J Nephrol. 2019 Jan-Feb;29(1):1-7. doi: 10.4103/ijn.IJN_150_18.

    PubMed 30814786

Questions about this trial

What is this clinical trial studying?

A study testing Bioimpedance in people with Hemodialysis Complication, run by Cishan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiovascular events (time frame: From first bioimpedance analysis done to 1 year later). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06573567, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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