Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients (Extended Poly Tetra Fluoro Ethylene)

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    220
  • sponsor
    Mansoura University
Updated on 22 January 2021
nephropathy
arteriovenous graft

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

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

Details
Condition Chronic renal failure, Stage 5 Chronic Kidney Disease, Chronic Kidney Disease Stage 5, CKD Stage 5, end stage renal disease, chronic renal disease, end-stage renal disease, esrd, end-stage renal failure, end stage kidney disease, end stage renal failure
Treatment Double vein cuffed ePTFE graft both at the inflow and outflow ends, single vein cuffed eTFE graft both at the inflow and outflow ends, ePTFE graft without any cuff
Clinical Study IdentifierNCT03405233
SponsorMansoura University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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 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

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
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