Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients

Not Applicable

Completed

• Conditions: Fluid Overload
• Interventions: Behavioral: Clinical judgement; Device: Bioimpedance Spectroscopy

• Registration Number: NCT02325856
• Lead Sponsor: An Hsin QingShui Clinic

Brief Summary

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

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 Timeline

• Study Start: 2013-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-25
• Results First Submitted: 2015-06-24
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-21
• Results First Posted: 2015-08-17
• Last Update Submitted: 2015-12-29
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Clinical judgement	Dry weight determined by clinical symptoms
Study group	Bioimpedance Spectroscopy	Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)

Primary Outcome Measures

Name	Time	Method
All-cause Hospitalization	1 year

Secondary Outcome Measures

Name	Time	Method
Complications During DW Adjustment	1 year	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).