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Quantification of Autonomic Nervous Activity During Hemodialysis

Primary Purpose

Chronic Kidney Disease on Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Analysis of the holter electrocardiogram
Sponsored by
University of Hyogo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease on Hemodialysis focused on measuring heart rate variability

Eligibility Criteria

undefined - 1 Year (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Graduate School of Applied Informatics, University of Hyogo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

measuring Holter electrocardiogram

Arm Description

Hotter ECG will be recorded continuously during hemodialysis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2016
Last Updated
April 25, 2016
Sponsor
University of Hyogo
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1. Study Identification

Unique Protocol Identification Number
NCT02754986
Brief Title
Quantification of Autonomic Nervous Activity During Hemodialysis
Official Title
Quantification of Autonomic Nervous Activity by Heart Rate Variability and Approximate Entropy in High Ultrafiltration Rate During Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hyogo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease on Hemodialysis
Keywords
heart rate variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
measuring Holter electrocardiogram
Arm Type
Experimental
Arm Description
Hotter ECG will be recorded continuously during hemodialysis
Intervention Type
Other
Intervention Name(s)
Analysis of the holter electrocardiogram
Other Intervention Name(s)
Analysis of heart rate variability with using holter electrocardiogram
Primary Outcome Measure Information:
Title
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.
Description
Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability.
Time Frame
4 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuko Mizuno-Matsumoto, Ph.D.
Organizational Affiliation
Graduate School of Applied Informatics, University of Hyogo
Official's Role
Study Director
Facility Information:
Facility Name
Graduate School of Applied Informatics, University of Hyogo
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Quantification of Autonomic Nervous Activity During Hemodialysis

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