Comparison of Tree Types of Distal Arteriovenous Fistulas: Snuffbox Fistula (SBAVF), Radiocephalic Fistula (RCAVF) and RCAVF With Venous Branch Patch.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Assisted primary patency:
研究概览
简要总结
This study aims to determine which type of distal arteriovenous fistula (SBAVF, RCAVF, and RCAVF with venous branch patch) is most clinically favorable.
The recommendations and scientific evidence do not suggest which option should be chosen initially.
The investigators expect that results will show which type of the anastomosis should be preferred.
详细描述
Research Project Objectives An important aspect in maintaining hemodialysis therapy is an optimal vascular access (AV) in patients with end-stage renal disease (ESRD). The radiocephalic arteriovenous (RCAVF), at the level of the wrist, or snuffbox fistula SBAVF stands out as the preferred vascular access (VA) for hemodialysis, due to its lower risk of infection and mortality compared to alternative options. The inherent properties of AVFs contributes not only to improved patient's safety but also to more efficient hemodialysis procedures. Despite this, AVFs has two disadvantages: a high early failure rate, occurring within one month after access creation, and a high failure rate during a maturation. Early failure rates differ between groups, ranging from 2-23% in brachiocephalic AVF (BCAVF) to up to 5-46%, in RCAVFs.[1] In the Jemcow study , a fistula was defined as mature when blood flow was greater than 500 ml/min and diameter of the cephalic vein exceeded 5 mm. Depending on when AVFs attained maturity, 53% of patients had successful AVF maturation, 36% had prolonged maturation i.e., within eight weeks, and 11% of AVFs failed to mature. Female sex, older patients, poor upper extremity vessels, distal placements and accesses with smaller diameter artery and vein are risk factors for failure to mature.
Despite advances in surgical techniques and perioperative care, fistula maturation remains a challenging part of hemodialysis access. This was shown by Bylsma et al., who conducted a meta-analysis that raised doubt on the AVF's utility in addressing ESRD.3 They evaluated the outcomes of more than 60.000 AVF access formations and found 1-year primary, primary assisted, and secondary patency rates of 64%, 73%, and 79%, respectively. However, only 26% of created fistulas were reported as mature at 6 months and 21% of fistulas were abandoned without use. In another meta-analysis study by Al-Jaishi, based on 37 studies, the risk of primary failure was 23% and primary patency rate was 60% at 1 year and 51% at 2 years.4 Clinical fistula maturation is the result of a crucial process in establishing functional VA for hemodialysis patients. It refers to the formation of a mature, useable AVF supplying the necessary blood volume for efficient dialysis. Data from a multicentre perspective cohort study by Robbin et al. of 602 patients who received a new single-stage AVF, demonstrated that unassisted and overall AVF clinical maturation can be predicted by three ultrasound parameters, fistula blood flow, diameter and depth. Performing such assessment, 6 weeks after surgery, provides valuable guidance regarding early intervention to facilitate maturation (e.g., percutaneous angioplasty or early planning of a second anastomosis) may increase maturation/utilization of the fistula and reduce exposure to central venous catheters.
The study will enroll individuals with and chronic kidney disease (CKD) in stage G4 and G5 including hemodialysis (HD) patients.
Clinical practice guidelines recommend distal arteriovenous fistula (AVF) RCAVF or SBAVF, rather than proximal arteriovenous anastomosis involving the brachial artery due to high risk of hemodialysis access hand ischemia and high flow heart failure. There have been no studies comparing the three aforementioned distal anastomosis in a single project.
Research hypothesis: There are differences between various types of AVF with regard to of early and late patency rates. The investigators also suppose that the type of AVFs may influence the postoperative increase in arteriovenous fistula diameter, blood flow, and, finally, AVF maturation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Aged >18 years
- •Chronic kidney disease with estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m2
排除标准
- •Heart failure of New York Heart Association functional class III or IV,
- •Episode of cardio- or cerebrovascular event or receiving intervention therapy within 3 months prior to screening.
- •The patient had the primary anastomosis in the past on ipsilateral extremity
结局指标
主要结局
Assisted primary patency:
时间窗: 36 months
The interval between VA creation and the first occlusion (thrombosis free VA survival) or measurement of patency including operative/endovascular interventions to maintain the VA.
Secondary patency
时间窗: 36 months
The interval between VA creation and the abandonment of this VA (i.e. thrombosis) after one or more interventions or the time of measurement of patency including achievement of a censored event (death, change of HD modality, loss of follow-up).
Primary patency:
时间窗: 12 months
The interval between VA creation and the first re-intervention (intervention free VA survival) for VA dysfunction or thrombosis, the time of measurement of patency or the time of its abandonment
次要结局
- Mature VA(6 weeks)
