Study of the Hemodynamic and Clinical Maturation of the Native Arteriovenous Fistula for Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Resistive index RI
研究概览
简要总结
Study of the features of hemodynamic and clinical maturation of the native arteriovenous fistula for hemodialysis.
详细描述
This is a prospective, single-center, observational study, investigating the clinical and hemodynamic features of maturation of hemodialysis native arteriovenous fistula (AVF). Hemodynamic features under investigation are the diameter of the feeding brachial artery, volume of flow (VF) measured with transcutaneous Duplex ultrasound (DUS), resistivity index (RI), diameter and wall thickness of the efferent vein, measured at days 1, 2, 3, 4, 5, 6, 7, 14, 21, 30, 60 and 90 post creation. Clinical features of maturation are the time of first access successful cannulation and the performance of three consecutive adequate dialysis sessions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodialysis patients
- •new native arteriovenous fistula (AVF)
排除标准
- •Patients not eligible for AVF creation
- •Patients with non compensated heart failure New York Heart Association stages 3 and 4
结局指标
主要结局
Resistive index RI
时间窗: day 90 post access creation
Calculation of the Resistive Index of the Brachial artery
Diameter of the efferent vein
时间窗: day 90 post access creation
Diameter of the the efferent vein in mm
Wall thickness of the efferent vein
时间窗: day 90 post access creation
Wall thickness of the efferent vein in mm
brachial artery diameter
时间窗: day 90 post access creation
Diameter of the Brachial artery in mm
Volume flow
时间窗: day 90 post access creation
Volume of flow in brachial artery in L/min
次要结局
- Time of first successful cannulation(30 and 60 days)
- Primary patency(6 months)
- Surgeon-Nephrologist access site selection concordance(At access creation (day 0))
- Successful hemodialysis(30 and 60 days)
研究者
Ioannis Emmanouel Giannikouris
Director Nephrologist
Medifil AE