Role of Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Morphology of lesion
研究概览
简要总结
Hemodialysis represents a life line of patients with end stage renal disease, who are commonly maintained on hemodialysis through catheters. Prolonged exposure to these catheters eventually damages the walls of veins, which results in stenosis at the local site. This condition is called central venous stenosis (CVS) and affects number of patients on hemodialysis in the United States and can compromise the dialysis efficacy. The current diagnostic modality for CVS is venography, which has several limitations. This study proposes to examine intravenous ultrasound (IVUS) as a potentially superior modality, which will provide additional information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ESRD (end stage renal disease) patients at BMC (Boston Medical Center)
- •Receiving hemodialysis
- •Has a dialysis access malfunction
- •Undergoing a diagnostic fistulogram for the dialysis access malfunction
排除标准
- 未提供
结局指标
主要结局
Morphology of lesion
时间窗: 18 months
The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.
Extent of stenosis
时间窗: 18 months
The severity of venous stenosis will be assessed using venogram and IVUS results. It will be calculated as the percentage diameter or area reduction, expressed as the ratio of the MLD or MLA to the RVD or RVA.
Length of lesions
时间窗: 18 months
The length of each lesion will be measured between points with \>50% diameter reduction in comparison to the referenced vein diameter and the referenced vein area at the pre-stenotic venous segment.
次要结局
未报告次要终点