Bioimpedance Analysis for Hemodialysis

NCT06573567 | Completed

• 1 other identifier: Bioimpedance_hemodialysis
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

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

  From first bioimpedance analysis done to 1 year later

Secondary Outcomes (5)

• The number of hemodialysis sessions with intradialytic hypotension

  From first bioimpedance analysis done to 1 year later

• The number of hemodialysis sessions with intradialytic cramps or postdialytic cramps

  From first bioimpedance analysis done to 1 year later

• The number of hemodialysis sessions with pitting edema

  From first bioimpedance analysis done to 1 year later

• The number of hemodialysis sessions with lung edema

  From first bioimpedance analysis done to 1 year later

• The number of hemodialysis sessions with non-function of arteriovenous shunt

  From first bioimpedance analysis done to 1 year later

Study Arms (2)

Bioimpedance

EXPERIMENTAL

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

Device: Bioimpedance

Control

PLACEBO COMPARATOR

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

Device: Control

Interventions

Bioimpedance DEVICE

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

Bioimpedance

Control DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cishan Hospital, Ministry of Health and Welfare: lead

Study Sites (1)

Cishan Hospital, MOHW, Taiwan

Kaohsiung City, 842, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 32295531 RESULT

• 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.

  PMID: 21688195 RESULT

• 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.

  PMID: 23415416 RESULT

• 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.

  PMID: 24583055 RESULT

• 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.

  PMID: 27620902 RESULT

• 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.

  PMID: 30814786 RESULT

Study Officials

• Han-Ming Kuo, Master

  Cishan Hospital, MOHW, Taiwan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Nephrology

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 27, 2024
• Study Start: September 1, 2024
• Primary Completion: February 11, 2026
• Study Completion: February 11, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: one year after the research published
• 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.

Locations

TW (1)