NCT02325856

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: An Hsin QingShui Clinic · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Bioimpedance Spectroscopy	Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.
BEHAVIORAL	Clinical judgement

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-12-25
• Last updated: 2016-02-02
• Results posted: 2015-08-17