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
NCT number | NCT02754986 |
Other study ID # | UHyogo |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | March 1, 2016 |
Last updated | April 25, 2016 |
Start date | March 2015 |
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 |
This study assesses autonomic nervous system function by power spectral analysis of RR interval dynamics in ultrafiltration subjects without blood pressure variation.
Status | Completed |
Enrollment | 35 |
Est. completion date | |
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 |
Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Graduate School of Applied Informatics, University of Hyogo | Kobe | Hyogo |
Lead Sponsor | Collaborator |
---|---|
University of Hyogo |
Japan,
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 |
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