NCT02325856

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 17, 2015

Completed
Last Updated

February 2, 2016

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

December 22, 2014

Results QC Date

June 24, 2015

Last Update Submit

December 29, 2015

Conditions

Fluid Overload

Keywords

HemodialysisBody Composition Monitor

Outcome Measures

Primary Outcomes (1)

  • All-cause Hospitalization

    1 year

Secondary Outcomes (1)

  • Complications During DW Adjustment

    1 year

Study Arms (2)

Study group

ACTIVE COMPARATOR

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

Device: Bioimpedance Spectroscopy

Control group

PLACEBO COMPARATOR

Dry weight determined by clinical symptoms

Behavioral: Clinical judgement

Interventions

Bioimpedance SpectroscopyDEVICE

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

Study group
Clinical judgementBEHAVIORAL
Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • MHD patients with age ≥ 18 and dialysis vintage ≥ 3 months

You may not qualify if:

  • coronary stents or pacemaker implantation
  • metallic devices in body, such as artificial joints or pins
  • contralateral or bilateral amputations
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Lim Paik-Seong
Organization
Department of Nephrology, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan
jamespslim@gmail.com
886-4-26581919

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2014

First Posted

December 25, 2014

Study Start

October 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 2, 2016

Results First Posted

August 17, 2015

Record last verified: 2015-07