Understanding the Patient-Centered Outcomes for One-stage and Two-stage Brachial Basilic Upper Extremity Arteriovenous Fistulas: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis
研究概览
简要总结
An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and two separate procedures is left to the surgeon. Both approaches are standard care. This study aims to compare patient-centered outcomes and quality of life by randomly assigning patients needing a BBAVF to either a one-stage or two-stage procedure.
详细描述
The aim of the pilot trial is to compare the outcomes of patients with end stage kidney failure (ESKD) who are candidates for a new brachial basilic arteriovenous fistula (BBAVF). Patients will be randomized to either one-stage or two-stage BBAVF procedure, both standard of care for creating BBAVF. The main outcome will be primary clinical functional patency, defined as successful use of BBAVF over a continuous 4-week period without any need for additional procedure on the BBAVF. The secondary outcomes are fistula-related complications, duration of central venous catheter (CVC) for those on dialysis, and quality of life (QoL) measures. The study hypothesizes that the primary patency will be superior following the two-stage BBAVF procedure compare to one-stage procedure. However, CVC-related complications are expected to be higher following the two-stage procedure compared to the one-stage procedure. Patient will be followed for a minimum duration of 12-months per subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •ESRD receiving hemodialysis in need for new hemodialysis access;
- •Candidate for one-stage and two-stage BVT procedure as judged by the enrolling investigator;
- •Greater than 3 mm diameter of upper arm basilic vein on venous duplex scan;
- •Life expectancy ≥ 12 months;
排除标准
- •Life expectancy < 12 months;
- •Brachial artery stenosis or occlusion;
- •A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis);
- •Current immunosuppressive medication, chemotherapy or radiation therapy;
- •Pregnancy or lactation
结局指标
主要结局
Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis
时间窗: 6 months
Functional clinical patency means the number of participants who were able to use their brachial basilic arteriovenous fistula (BBAVF) successfully for dialysis within 6 months of surgical creation. It refers to using two dialysis needles in at least 75% of dialysis sessions over four weeks without need for additional procedure or surgery, as determined by their providers.
Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis
时间窗: 6 months
Functional clinical patency means the number of participants who were able to use their brachial basilic arteriovenous fistula (BBAVF) successfully for dialysis within 6 months of surgical creation. It refers to using two dialysis needles in at least 75% of dialysis sessions over four weeks without need for additional procedure or surgery, as determined by their providers.
次要结局
- Patient-Reported Outcomes Measurement Information System Scores Over 6 Months(6-month)
- Number of Participants Who Had Catheter Related Complications(6 months)
- Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation(6 months)
- Number of Participants Who Had Catheter Related Complications(6 months)
- Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation(6 months)
- Patient-Reported Outcomes Measurement Information System Scores Over 6 Months(6-month)
研究者
Tze-Woei Tan
Clinical Associate Professor of Surgery
University of Arizona