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临床试验/NCT03140345
NCT03140345Unknown不适用

Integrative Nursing Assessment on Hemodialysis Vascular Access

National Taipei University of Nursing and Health Sciences1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年6月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Patency of hemodialysis vascular access

研究概览

简要总结

The aim of this two-year study is to explore the relationship among function of HVA, nail-fold capillaries and TCM constitutions based on hybridizing data mining techniques. This study will not only improve our understanding on the expressions of function of HVA, nailfold capillaries and tendency of TCM patterns, but also demonstrate the fundamental knowledge of a novel healthcare model on hemodialysis vascular access.

详细描述

Background

The effectiveness of hemodialysis (HD) depends on HD vascular access (HVA). Individualized prevention based on TCM constitutions can help persons to restore balance and prevent disease. To prevent the negative development of HVA and maintain HVA patency, development of an integrative model of HVA should be an important issue in nephrological nursing. To establish an integrative healthcare model of HVA, the understanding of the relationships between the common TCM constitution patterns of HD patients and the functions of HVA must be improved. In traditional Chinese medicine (TCM), health is conceived as a balance among the elements of the body. Published articles revealed that vascular access surgery, hemodynamic disorder and HD might impact HVA and the microcirculation of HD patients. Hence, changes of hand microcirculation might may come with and indicate the degeneration of HVA.

Purpose

The aims of this two-year study are as follows.

  1. To identify major risk factors for the functions of HVA.
  2. To measure the microcirculation and constitutions of HD patients.
  3. To explore associations among risk factors for the functions of HVA, TCM constitutions and the characteristics of nail-fold capillaries.
  4. To propose an HVA assessment model.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • having ESRD and needing hemodialysis three times weekly, having undergone hemodialysis ≥ 3 months, speaking Chinese or Taiwanese, and agreeing for data to be collected and stored in a database for analysis

排除标准

  • life expectancy ≤ 3 months, having a malignant tumor, having unstable hemodynamics, having had a cerebrovascular accident, having acute heart failure, having acute bronchitis with acute exacerbation, or having had a severe infection in the last three months

结局指标

主要结局

Patency of hemodialysis vascular access

时间窗: through study completion, an average of 2 year

Patency of hemodialysis vascular access is defined as 1) the interval from the time of access placement to the time of access abandonment, any patency reestablish intervention, or create new access; and 2) the number of hemodialysis vascular access dysfunction events. The time of access placement and the time of the intervention, as well as number of hemodialysis vascular access dysfunction events will be retrieved from medical records. The interval from the time of access placement to the intervention will be calculated in days.

次要结局

  • Distribution of the traditional Chinese medicine constitution patterns of HD patients(8 months)
  • Nail-fold blood flow velocity of the hands of the paticipants(2 years)
  • Abnormalities of nail-fold capillary in the hands of participants.(2 years)
  • Total vessel density of nail-fold capillary in the hands of participants.(2 years)
  • Diameter of nail-fold capillary in the hands of participants.(2 years)

研究者

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

Chiang, Hui-Chu

Assistant Professor

National Taipei University of Nursing and Health Sciences

研究点 (1)

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