Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients

Fluid Overload Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325856
• Other study ID #: ABISAD-3
• Status: Completed
• Phase: N/A
• First received: December 22, 2014
• Last updated: December 29, 2015
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: July 2015
• Source: An Hsin QingShui Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fluid Overload

Intervention

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

Behavioral:
• Clinical judgement

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
An Hsin QingShui Clinic	Nephrocare AsiaPacific

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Hospitalization		1 year	No
Secondary	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	No