A Prospective Randomized Controlled Trial of the Clinical Effectiveness of Obligatory Versus Elective Duplex Ultrasound Scanning Prior to Arteriovenous Fistula Formation for Haemodialysis Vascular Access in a University Teaching Hospital.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Primary failure of access (immediate/early thrombosis or failure to mature).
研究概览
简要总结
Dialysis patients have their blood filtered by a machine as their kidneys no longer work. To get blood in and out of these patients it is possible to perform a surgical procedure to increase to size and durability of a vein in the arm to allow repeated needle insertion. This enlarged vein is called a fistula. There is some evidence that ultrasound scanning the blood vessels in the arm before surgery can improve the chances of a successful procedure. The investigators aim to test whether scanning all patients is better than scanning only those who are difficult to assess by physical examination alone.
详细描述
We will recruit all patients undergoing primary vascular access procedures in our unit who meet inclusion criteria. They will be randomised to either surgery based on clinical findings with duplex ultrasound only if requested by surgeon, or routine duplex ultrasound prior to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Specific inclusion criteria necessary for invitation to study participation; Patients referred to vascular consultants for primary AV fistula formation (or primary fistula in that limb) for haemodialysis access.
- •General inclusion criteria;
- •Ability to give informed written consent
排除标准
- •Specific exclusion criteria;
- •Previous arterial or venous surgery/intervention performed on target limb.
- •Known thrombophilic or thrombotic pathology.
- •Aged under 18 at time of referral
- •General exclusion criteria;
- •Inability to give informed written consent
- •Inability to attend follow up appointments
研究组 & 干预措施
Control group - selective duplex
Patients will receive a duplex ultrasound only if specifically requested following physical examination.
Obligatory Duplex scan
Patients will receive a duplex ultrasound regardless of clinical findings. Arterial and venous duplex ultrasound examination
干预措施: Arterial and venous duplex ultrasound examination (Procedure)
结局指标
主要结局
Primary failure of access (immediate/early thrombosis or failure to mature).
时间窗: 30 days
次要结局
- Site of fistula created(within 1 month of recruitment)
- Surgeon grade(open ended)
- Assisted primary patency - being the interval from placement until the time of measurement of patency, including intervening manipulations(open ended)
- Secondary patency - The interval from placement until time of patency measurement including intervening manipulations(open ended)
- Functional primary patency - being the interval from the time of access placement until any intervention designed to maintain or re-establish patency or the time of measurement of patency during which the AVF provides dialysis access.(open ended)