A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 103
- 试验地点
- 14
- 主要终点
- Number of Catheter-free dialysis days
研究概览
简要总结
This study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions
详细描述
This study will determine the effects of arteriovenous (AV) fistula versus AV graft vascular access strategy on the rate of catheter-free dialysis days and access-related infections - costs associated with the dialysis vascular access - patient-reported satisfaction with different processes of vascular access care (catheter, fistula, or graft) - and the relationship between preoperative functional status and incidence of fistula or graft maturation failure
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years or older
- •End-stage kidney disease on hemodialysis via a central venous catheter
- •Hemodialysis is the long-term modality of treatment for end-stage kidney disease
- •Central venous catheter is the sole vascular access used for hemodialysis at the time of referral for arteriovenous access creation
- •Referred by patient's nephrologist for placement of arteriovenous access
- •At least one of the following comorbid conditions: cardiovascular disease, peripheral vascular disease, and/or diabetes mellitus
- •Medically and surgically eligible to undergo surgical placement of an arteriovenous access, deemed by the treating healthcare providers
- •Native vasculature deemed preoperatively to be suitable for surgical creation of either type of arteriovenous access (arteriovenous fistula or arteriovenous graft) in the opinion of the surgeon
- •Patient agreed to study participation and signed the informed consent
排除标准
- •Severe cardiac disease defined as presence of either of the following three conditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant, or ventricular assist device
- •Known or suspected central vein stenosis or vascular obstruction on the side of planned study access creation, unless corrected prior to randomization
- •Planned arteriovenous fistula creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices)
- •Anticipated kidney transplant within 12 months
- •Anticipated conversion to peritoneal dialysis within 12 months
- •Anticipated transfer of nephrology care to a clinic outside the study participating centers within 12 months
- •Anticipated non-compliance with medical care based on physician judgment
- •A condition in which, in the opinion of the site PI renders the patient not a good candidate for study participation.
研究组 & 干预措施
graft surgically placed
Randomized group to have surgically placed graft for permanent hemodialysis access
干预措施: AV graft (Device)
fistula surgically placed
Randomized group to have surgically placed fistula for permanent hemodialysis access
干预措施: surgical intervention for creation of a fistula (Procedure)
结局指标
主要结局
Number of Catheter-free dialysis days
时间窗: Until death, collected up to 4 years
Determine the effects of arteriovenous (AV) fistula vs. AV graft vascular access strategy on the rate of catheter-free dialysis days
Number of Infections
时间窗: Until death, collected up to 4 years
Access-related infections - catheter-related blood-stream infection, with or without sepsis, requiring hospitalization for treatment
次要结局
- Functional patency of study fistula or graft access(Until death, collected up to 4 years)
- Vascular access-related cost per patient-year(Year 2)
- Incidence rate of study fistula/graft primary maturation failure(hour 72, Month 3, Month 6, and Year 4)
- Time to successful fistula/graft access cannulation(Until death, collected up to 4 years)
- Incidence rate of fistula/graft access hemodialysis suitability(Month 6)
- Rate of adjuvant endovascular and surgical procedures(Until death, collected up to 4 years)