Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients

NCT ID: NCT02325856

Last Updated: 2016-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-10-31

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.

Conditions

Fluid Overload

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study group

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

Group Type: ACTIVE_COMPARATOR

Bioimpedance Spectroscopy

Intervention Type: DEVICE

Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.

Control group

Dry weight determined by clinical symptoms

Group Type: PLACEBO_COMPARATOR

Clinical judgement

Intervention Type: BEHAVIORAL

Interventions

Bioimpedance Spectroscopy

Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.

Intervention Type: DEVICE

Clinical judgement

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nephrocare AsiaPacific

UNKNOWN

Sponsor Role: collaborator

An Hsin QingShui Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ABISAD-3

Identifier Type: -

Identifier Source: org_study_id