Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients

An Hsin QingShui Clinic

Status: Completed

Conditions: Fluid Overload

Treatments: Behavioral: Clinical judgement; Device: Bioimpedance Spectroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02325856

ABISAD-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 298 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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298 participants in 2 patient groups, including a placebo group

Study group

Active Comparator group

Description:

Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)

Treatment:

Device: Bioimpedance Spectroscopy

Control group

Placebo Comparator group

Description:

Dry weight determined by clinical symptoms

Treatment:

Behavioral: Clinical judgement