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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02325856
Other study ID # ABISAD-3
Secondary ID
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


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
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