End Stage Renal Disease
Conditions
Keywords
ESRD, ePTFE, neointemal hyperplasia
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
Interventions
PROCEDUREDouble vein cuffed ePTFE graft both at the inflow and outflow ends
Vein cuff is obtained from a segment of one of the arm veins (cephalic or basilica) after incising it longitudinally and wrapped around both ends of PTFE Graft
PROCEDUREsingle vein cuffed eTFE graft both at the inflow and outflow ends
Vein cuff is obtained from a segment of one of the arm veins (cephalic or basilica) after incising it longitudinally and wrapped around the venous end of PTFE Graft
PROCEDUREePTFE graft without any cuff
anastmosis between arterial and venous side usinf non cuffed ePTFE graft
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
the patients do not know which group will they belong the duplex operator will not know the details of operative data
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients with end stage renal diseases and GFR less than 30 2. By clinical examination in ability to palpate distal or proximal upper limb veins 3. By duplex examination the diameter of cephalic or basilic veins are less than 3 mm or reported to be incompressible 4. Patients with previous history of failed attempts of autogenous vein creation 5. 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
1. All patients with palpable suitable forearm or arm veins 2. Patients with baseline blood pressure less than 110/70 3. Brachial artery of diameter less than 4 mm 4. Patients with ligated brachial artery 5. Patients with history of central vein stenosis 6. Patients with immunodeficiency states
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary patency | 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
| Measure | Time frame | Description |
|---|---|---|
| secondary patency | 2 years after restoration of patency | comparing secondary patency between the double cuffed, single cuffed and non cuffed ePTFE graft secondary patency means how long will the graft be patent after thormobectomy to a thrombosed graft |
Countries
Egypt
Contacts
Primary ContactHussein mohamed Abdelaziz, PHD
Outcome results
None listed