End-stage renal disease, vascular access
Conditions
Interventions
Subjects will be randomized into three study groups with a different surgical strategy for the creation of a vascular access for hemodialysis:
1. Autologous arteriovenous fistula creation (recommended
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 65 years or older 2. End-stage renal disease with unlikely recovery of kidney function according to the attending nephrologist 3. Hemodialysis is the intended long-term modality of treatment for end-stage renal disease 4. Fit for vascular access surgery as determined by the local multidisciplinary vascular access team 5a. Expected to start hemodialysis treatment within 6 months at the time of treatment assignment; or 5b. Treated with hemodialysis for 6 months or less at the time of treatment assignment using a tunneled or non-tunneled central venous catheter for vascular access 6. Planning to remain in one of participating dialysis centers for at least 1 year 7. Suitable vascular anatomy for all types of vascular access based on duplex ultrasound of the arms, defined as: - at least one suitable configuration for an arteriovenous fistula using minimal arterial and venous diameters of 2mm for radiocephalic fistulas and 3mm for brachiocephalic and brachiobasilic fistulas; - at least one suitable configuration for an arteriovenous graft using minimal arterial and venous diameters of 3mm and 4mm, respectively; and - at least one open internal jugular vein for a central venous catheter.
Exclusion criteria
Exclusion criteria: 1. Patent arteriovenous fistula or graft already in place 2. Prior unsuccessful arteriovenous fistula or graft vascular access surgery 3. Kidney transplantation planned within 6 months 4. Metastatic malignancies or other condition associated with a life expectancy of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of interventions required for each year of hemodialysis treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported outcome measures (SF-12 / DSI / SF-VAQ) Health care costs Access-related complications Days in hospital Mortality | — |
Countries
Netherlands
Contacts
Public ContactM.G.J. Snoeijs
Maastricht Universitair Medisch Centrum +
Outcome results
None listed