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临床试验/NCT02754986
NCT02754986已完成不适用

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

University of Hyogo2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
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.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
— 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with stable undergoing hemodialysis without hanging in blood pressure during hemodialysis.

排除标准

  • 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

结局指标

主要结局

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.

时间窗: 4 hours

Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yoshihiro Tsuji

clinical engineer

University of Hyogo

研究点 (2)

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