Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 主要终点
- Stenosis postoperative (duplex ultrasonography)
研究概览
简要总结
Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is recognized as the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs. Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.
详细描述
Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs.
Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Mentally competent
- •Written informed consent
- •Age 18 years and older
- •Indication for brachiocephalic AVF in HagaZiekenhuis
- •Patient is able to complete the follow-up evaluation
排除标准
- •Pregnancy
研究组 & 干预措施
Vascular clamps
Patients randomized to the use of vascular clamps to obtain a bloodless field during arteriovenous fistula surgery (standard protocol).
Tourniquet
Patients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery.
干预措施: Tourniquet (Other)
结局指标
主要结局
Stenosis postoperative (duplex ultrasonography)
时间窗: 6 weeks
Luminal vessel diameter
次要结局
- AVF occlusion(Within 3 months after surgery)
- Bleeding(Within 3 months after surgery)
- Infection(Within 3 months after surgery)
- Need for reintervention(1 year postoperative)
- Duration of surgery(During surgery)
- Pseudoaneurysm(Within 3 months after surgery)