Bioimpedance Analysis for Hemodialysis

Last updated: January 18, 2025
Sponsor: Cishan Hospital, Ministry of Health and Welfare
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Bioimpedance

Control

Clinical Study ID

NCT06573567
Bioimpedance_hemodialysis
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has received hemodialysis >= 3 months

  • Has at least 1 pair of intact same-side upper extremity and lower extremity

Exclusion

Exclusion Criteria:

  • Pregnant

  • With a cardiac pacemaker

  • With metallic implants that may interfere with measurements (cardiac stentsacceptable)

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Bioimpedance
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • Cishan Hospital, MOHW, Taiwan

    Kaohsiung, 842
    Taiwan

    Active - Recruiting

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