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OpenTrials
Completed

NCT Number: NCT02754986

Quantification of Autonomic Nervous Activity During Hemodialysis

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

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Key information

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate School of Applied Informatics, University of Hyogo

Kobe, Hyōgo, 650-0047, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analysis of the holter electrocardiogram

Other

Other names: Analysis of heart rate variability with using holter electrocardiogram

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.

    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.

Sponsors and collaborators

Lead sponsor

University of Hyogo

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
First posted
Apr 28, 2016
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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