Clinical trial NCT06573567: Bioimpedance Analysis for Hemodialysis
Official title: Target Weight Guided by Bioimpedance Analysis in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodialysis Complication
Lead sponsor: Cishan Hospital, Ministry of Health and Welfare
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: From first bioimpedance analysis done to 1 year later
Secondary outcomes:
measure: The number of hemodialysis sessions with intradialytic hypotension
timeFrame: From first bioimpedance analysis done to 1 year later
measure: The number of hemodialysis sessions with intradialytic cramps or postdialytic cramps
timeFrame: From first bioimpedance analysis done to 1 year later
measure: The number of hemodialysis sessions with pitting edema
timeFrame: From first bioimpedance analysis done to 1 year later
measure: The number of hemodialysis sessions with lung edema
timeFrame: From first bioimpedance analysis done to 1 year later
measure: The number of hemodialysis sessions with non-function of arteriovenous shunt
timeFrame: From first bioimpedance analysis done to 1 year later
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Cishan Hospital, MOHW, Taiwan
Study officials:
affiliation: Cishan Hospital, MOHW, Taiwan
name: Han-Ming Kuo, Master
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.