FLOW
- Conditions
- Hemodialysis vascular access
- Registration Number
- NL-OMON20487
- Lead Sponsor
- Maastricht University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 518
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. Maturation: outflow vein diameter of at least 5mm (not applicable for grafts) and access flow volume of at least 500mL/min; and
b. Functional: 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.
4. Planning to remain in one of the participating dialysis centers for at least 1 year.
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 or switch to peritoneal dialysis 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Access-related intervention rate.
- Secondary Outcome Measures
Name Time Method Complications, medical costs, patient-reported outcomes (SF-VAQ), and the quality of the surveillance program.