NCT02754986

Brief Summary

This study assesses autonomic nervous system function by power spectral analysis of RR interval dynamics in ultrafiltration subjects without blood pressure variation.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
Last Updated

April 28, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

March 1, 2016

Last Update Submit

April 25, 2016

Conditions

Chronic Kidney Disease on Hemodialysis

Keywords

heart rate variability

Outcome Measures

Primary Outcomes (1)

  • The outcome measures was low frequency power (LF, ms2) to high frequency power (HF, ms2) ratio (LF/HF ratio) of heart rate variability. The three subject groups with difference ultrafiltration were compared by LF/HF ratio during hemodialysis session.

    Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability.

    4 hours

Study Arms (1)

measuring Holter electrocardiogram

EXPERIMENTAL

Hotter ECG will be recorded continuously during hemodialysis

Other: Analysis of the holter electrocardiogram

Interventions

Analysis of the holter electrocardiogramOTHER
Also known as: Analysis of heart rate variability with using holter electrocardiogram
measuring Holter electrocardiogram

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients with stable undergoing hemodialysis without hanging in blood pressure during hemodialysis.

You may not qualify if:

  • Patients with chronic atrial fibrillation
  • Patients with frequent ventricular premature beats
  • Patients with a permanent pacemaker
  • Patients with taking antihypertensive drugs
  • Patients with medical treatment due to changes in blood pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate School of Applied Informatics, University of Hyogo

Kobe, Hyōgo, 650-0047, Japan

Location

Study Officials

  • Yuko Mizuno-Matsumoto, Ph.D.

    Graduate School of Applied Informatics, University of Hyogo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical engineer

Study Record Dates

First Submitted

March 1, 2016

First Posted

April 28, 2016

Study Start

March 1, 2015

Primary Completion

August 1, 2015

Last Updated

April 28, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Locations

JP(1)