Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients

Study Overview
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Brief Summary
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A reasonable and simple algorithm was used to guide the dry weight determination with Body Composition Monitor with the principle of Bioimpedance Spectroscopy (BCM-BIS) and analyze the feasibility of this algorithm and evaluate the influence of BCM-BIS-guided fluid management on the incidence of dialysis morbidities and clinical outcomes in maintenance hemodialysis (MHD) patients.

Detailed Description
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298 MHD patients in 6 hemodialysis centers in Taiwan were enrolled in this randomized controlled study. All the participants were randomized into study group ( dry weight (DW) determined by BCM-BIS) and control group ( dry weight determined by clinical symptoms) with stratification by diabetes mellitus and centers. Body composition monitor based on bioimpedance spectroscopy (BCM-BIS) was performed monthly and concomitant biochemical data and clinical outcomes were collected. Intra-dialysis complications were recorded in every dialysis session. Primary outcome was all-cause hospitalization. Secondary outcomes included 1) complications during DW adjustment 2) intra-dialysis morbidities 3) hypertension 4) mortality 5) acute fluid overload (AFO) or cardiovascular (CV)-related events. The clinical feasibility of the BCM-BIS algorithm was also inspected. Statistical methods: a software (SAS) 9.3 was used for statistical analysis in this study. R 3.0 was used for graphic presentation of parts of the results. Relative risk, incidence rate ratio and Fisher's exact test were used to compare the discrete outcomes in both groups. Survival analysis was used for time-related events. Repeated-measured and longitudinal data were analyzed with the generalized linear mixed model (GLMM) through the procedure for continuous variables (PROC MIXED) and for discrete variables (PROC GLIMMIX) in SAS.

Official Title
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Effect of Post-dialysis Weight Evaluated With Bioimpedance Spectroscopy on Dialysis Morbidities and Clinical Outcomes in Hemodialysis Patients: A Randomized Controlled Trial

Conditions
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Fluid Overload

Intervention / Treatment
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* Device: Bioimpedance Spectroscopy
* Behavioral: Clinical judgement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MHD patients with age ≥ 18 and dialysis vintage ≥ 3 months Exclusion Criteria: coronary stents or pacemaker implantation metallic devices in body, such as artificial joints or pins contralateral or bilateral amputations pregnancy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool) | Device: Bioimpedance Spectroscopy<br>* Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.<br>|
| Placebo Comparator: Control group<br>Dry weight determined by clinical symptoms | Behavioral: Clinical judgement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Hospitalization |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications During DW Adjustment | we wanted to compared whether the dialysis-related complications are different when DW (dry weight) is adjusted, no matter according to BCM (body composition monitor) results or clinical judgement, in both groups. The result is expressed as the percentage of months in which complications happened when DW adjustment presented (using total months which DW adjustments are present as denominator). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Body Composition Monitor