Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-09-01
2026-04-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Bioimpedance
Use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month
Bioimpedance
Experimental: use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month
Control
Bioimpedance analysis done, but the results will be masked to the participants, care providers and outcome evaluators
Control
Placebo Comparator: the measurements will also be obtained once per month, but not revealed to the participants and the care providers
Interventions
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Bioimpedance
Experimental: use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month
Control
Placebo Comparator: the measurements will also be obtained once per month, but not revealed to the participants and the care providers
Eligibility Criteria
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Inclusion Criteria
* Has at least 1 pair of intact same-side upper extremity and lower extremity
Exclusion Criteria
* With a cardiac pacemaker
* With metallic implants that may interfere with measurements (cardiac stents acceptable)
18 Years
ALL
No
Sponsors
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Cishan Hospital, Ministry of Health and Welfare
OTHER
Responsible Party
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Han-ming Kuo
Director, Division of Nephrology
Principal Investigators
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Han-Ming Kuo, Master
Role: STUDY_CHAIR
Cishan Hospital, MOHW, Taiwan
Locations
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Cishan Hospital, MOHW, Taiwan
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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Bioimpedance_hemodialysis
Identifier Type: -
Identifier Source: org_study_id
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