Quantification of Autonomic Nervous Activity During Hemodialysis

Chronic Kidney Disease on Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754986
• Other study ID #: UHyogo
• Status: Completed
• Phase: N/A
• First received: March 1, 2016
• Last updated: April 25, 2016
• Start date: March 2015

Study information

• Verified date: March 2016
• Source: University of Hyogo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease on Hemodialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Analysis of the holter electrocardiogram

Locations

Country	Name	City	State
Japan	Graduate School of Applied Informatics, University of Hyogo	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
University of Hyogo

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No