Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Fluid Overload
• Intervention / Treatment: Device: Bioimpedance Spectroscopy; Behavioral: Clinical judgement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 298
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

MHD patients with age ≥ 18 and dialysis vintage ≥ 3 months

Exclusion Criteria:

1. coronary stents or pacemaker implantation
2. metallic devices in body, such as artificial joints or pins
3. contralateral or bilateral amputations
4. pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: An Hsin QingShui Clinic
• Collaborators: Nephrocare AsiaPacific

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimate): December 25, 2014

Study Record Updates

• Last Update Posted (Estimate): February 2, 2016
• Last Update Submitted That Met QC Criteria: December 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Hemodialysis; Body Composition Monitor
• Other Study ID Numbers: ABISAD-3