Quantification of Autonomic Nervous Activity During Hemodialysis

April 25, 2016 updated by: Yoshihiro Tsuji, University of Hyogo

Quantification of Autonomic Nervous Activity by Heart Rate Variability and Approximate Entropy in High Ultrafiltration Rate During Hemodialysis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability in hemodialysis patients without blood pressure variations during HD session.

The subjects will be divided into 3 groups, those with UFR < 10 ml/hr/kg; ≥10 ml/hr/kg but ≤ 15 ml/hr/kg; and >15 ml/hr/kg, and Holter ECG are recorded continuously during HD session using frequency analysis of RR intervals.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0047
        • Graduate School of Applied Informatics, University of Hyogo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: measuring Holter electrocardiogram
Hotter ECG will be recorded continuously during hemodialysis
Other: Analysis of the holter electrocardiogram
Other Names:
  • Analysis of heart rate variability with using holter electrocardiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 4 hours
Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hyogo

Investigators

  • Study Director: Yuko Mizuno-Matsumoto, Ph.D., Graduate School of Applied Informatics, University of Hyogo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHyogo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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