Trial Outcomes & Findings for Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients (NCT NCT02325856)

NCT ID: NCT02325856

Last Updated: 2016-02-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 298 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2016-02-02

Participant Flow

Participant milestones

Measure	Study Group Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool) Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.	Control Group Dry weight determined by clinical symptoms
Overall Study STARTED	148	150
Overall Study COMPLETED	128	123
Overall Study NOT COMPLETED	20	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients

Baseline characteristics by cohort

Measure	Study Group n=148 Participants Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool) Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.	Control Group n=150 Participants Dry weight determined by clinical symptoms	Total n=298 Participants Total of all reporting groups
Age, Continuous	62.7 years STANDARD_DEVIATION 12.1 • n=5 Participants	62.1 years STANDARD_DEVIATION 11.5 • n=7 Participants	62.4 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	70 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	80 Participants n=7 Participants	145 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Measure	Study Group n=128 Participants Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool) Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.	Control Group n=123 Participants Dry weight determined by clinical symptoms
All-cause Hospitalization	0.52 hospitalizations per patient-year Interval 0.44 to 0.61	0.54 hospitalizations per patient-year Interval 0.46 to 0.63

SECONDARY outcome

Timeframe: 1 year

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).

Outcome measures

Measure	Study Group n=816 months when dry weight adjustment happen Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool) Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.	Control Group n=735 months when dry weight adjustment happen Dry weight determined by clinical symptoms
Complications During DW Adjustment	11.76 % of months in which compli	30.88 % of months in which compli

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lim Paik-Seong

Department of Nephrology, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan

Phone: 886-4-26581919

Email: jamespslim@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place