NCT02376361已完成不适用
Hemodialysis Access Surveillance Evaluation Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 436
- 试验地点
- 6
- 主要终点
- Hemodialysis Access Thrombosis Rate
研究概览
简要总结
The purpose of the study is to learn if monitoring dialysis access blood flow during dialysis treatment with a transonic machine (an ultrasound technique) will prevent (or reduce) the development of dialysis access thrombosis (clotting).
Investigators would like to study if monitoring with a specific technique called ultrasound dilution technique can help prevent problems with access when compared to what is the current standard of care for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hemodialysis patients undergoing dialysis therapy via an upper extremity arteriovenous access (arteriovenous fistula or an arteriovenous graft) will be enrolled to have monthly surveillance flow measurement using Transonic system or physical examination of the arteriovenous access by qualified person at least once a month for a period of 2 years.
排除标准
- •Patients requiring surgical intervention on the arteriovenous access.
- •History of access thrombosis (one or more access thrombosis of the current arteriovenous access).
- •Patients with signs of access infection.
- •Patients with a malignancy.
- •Patients with life expectancy of less than six months.
- •Unable to understand the study.
- •Unable to sign the consent form.
- •Patients with psychiatric disorder.
- •Age less than 18 or greater than 80 years.
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Hemodialysis Access Thrombosis Rate
时间窗: Up to 24 months
Evaluate the reduction of hemodialysis access thrombosis rate
次要结局
- Number of Participants With a Tunneled Hemodialysis Catheter(Up to 24 months)
- Tunneled Hemodialysis Catheter Rate(Up to 24 months)
- Number of Hemodialysis Access Angiogram and Angioplasty Procedures(Up to 24 months)
- Number of Hemodialysis Access Thrombectomy Procedures(Up to 24 months)
研究者
Loay Salman, MD
Professor of Medicine
Albany Medical College
研究点 (6)
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