Quantification of Autonomic Nervous Activity During Hemodialysis

NCT ID: NCT02754986

Last Updated: 2016-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Kidney Disease on Hemodialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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measuring Holter electrocardiogram

Hotter ECG will be recorded continuously during hemodialysis

Group Type EXPERIMENTAL

Analysis of the holter electrocardiogram

Intervention Type OTHER

Interventions

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Analysis of the holter electrocardiogram

Intervention Type OTHER

Other Intervention Names

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Analysis of heart rate variability with using holter electrocardiogram

Eligibility Criteria

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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
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Hyogo

OTHER

Sponsor Role lead

Responsible Party

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Yoshihiro Tsuji

clinical engineer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuko Mizuno-Matsumoto, Ph.D.

Role: STUDY_DIRECTOR

Graduate School of Applied Informatics, University of Hyogo

Locations

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Graduate School of Applied Informatics, University of Hyogo

Kobe, Hyōgo, Japan

Site Status

Countries

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Japan

Other Identifiers

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UHyogo

Identifier Type: -

Identifier Source: org_study_id

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