Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- primary patency
研究概览
简要总结
this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long-term patency of each modality
详细描述
End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years.End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years. Haemodialysis (HD) is a lifeline therapy for patients with ESRD. A proportion of hemodialysis patients exhaust all options for permanent vascular access (fistula or graft) in both upper extremities.ePTFE grafts are easily subjected to graft outflow tract intimal hyperplasia, which may lead to graft outlet stenosis and graft thrombosis after a certain period of usage. The commonest cause of PTFE graft failure is intimal hyperplasia (IH) at the venous anastomoses. our study aims to evaluate the influence of double cuffed ePTFE grafts with autologous vein cuffs on the long-term patency of dialysis access, and compare the clinical patency and the complications occurring with the usage of the double cuffed graft to that with standard non cuffed grafts in chronic renal hemodialysis therapy.
this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long term patency of each modality
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
- Double (Participant, Outcomes Assessor)
盲法说明
the patients do not know which group will they belong the duplex operator will not know the details of operative data
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with end stage renal diseases and GFR less than 30
- •By clinical examination in ability to palpate distal or proximal upper limb veins
- •By duplex examination the diameter of cephalic or basilic veins are less than 3 mm or reported to be incompressible
- •Patients with previous history of failed attempts of autogenous vein creation
- •Patients with border line cephalic or basilica vein (3mm) and on intraoperative the vein diameter appears to be unsuitable (less than 3 mm).
排除标准
- •All patients with palpable suitable forearm or arm veins
- •Patients with baseline blood pressure less than 110/70
- •Brachial artery of diameter less than 4 mm
- •Patients with ligated brachial artery
- •Patients with history of central vein stenosis
- •Patients with immunodeficiency states
结局指标
主要结局
primary patency
时间窗: 2 years for each patient after the operation
comparing primary patency between the double cuffed, single cuffed and non cuffed ePTFE graft primary patency means how long will the graft be patent after the first intervention
次要结局
- secondary patency(2 years after restoration of patency)
研究者
Amr Elshafie
Assistant Lecturer of vascular surgery
Mansoura University