end-stage renal disease Vascular access renal dialysis
Conditions
Interventions
Intervention group:
Patients are referred for correction of the underlying stenosis when clinical
signs of flow dysfunction are present. These include physical signs, problems
during dialysis, or an
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 years or older. 2. End-stage renal disease with unlikely recovery of kidney function according to the attending nephrologist. 3. Arteriovenous fistula or arteriovenous graft as hemodialysis vascular access that fulfills both of the following criteria at the time of trial enrollment: a. Vascular access flow volume of at least 500mL/min; and b. Functional vascular access: the vascular access was cannulated with 2 needles and achieved the prescribed access circuit flow in at least 6 dialysis sessions over the past 30 days. Patients who have single needle hemodialysis for reasons other than vascular access dysfunction (e.g. for nocturnal hemodialysis) but who can be cannulated with 2 needles for flow measurements and fulfill the other requirements for a functional vascular access can be enrolled as well. 4. Planning to remain in one of the participating dialysis centers for at least 1 year.
Exclusion criteria
Exclusion criteria: 1. Arteriovenous fistulas with multiple venous outflow paths upstream of the cannulation sites, that are not suitable for flow volume measurements using ultrasound dilution (e.g. Gracz fistulas and Ellipsys or WavelinQ endovascular fistulas). 2. Home hemodialysis. 3. Thrombosis of the current vascular access in the past year. 4. Planned access-related intervention. 5. Living donor kidney transplantation, switch to peritoneal dialysis, or switch to home hemodialysis planned within 6 months. 6. Life expectancy of less than 6 months, in the opinion of the attending nephrologist. 7. Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the access-related intervention rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are complications, medical and societal costs, patient-reported outcomes, and the quality of the surveillance program. | — |
Countries
Netherlands
Contacts
Public ContactMGJ Snoeijs
Maastricht Universitair Medisch Centrum +
Outcome results
None listed