Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients: a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- End Stage Renal Disease
- Sponsor
- Mansoura University
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- primary patency
- Last Updated
- 8 years ago
Overview
Brief Summary
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
Detailed Description
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
Investigators
Amr Elshafie
Assistant Lecturer of vascular surgery
Mansoura University
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
primary patency
Time Frame: 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
Secondary Outcomes
- secondary patency(2 years after restoration of patency)