NL-OMON54091
Recruiting
N/A
Flow dysfunction of hemodialysis vascular access: a randomized controlled trial on the effectiveness of surveillance of arteriovenous fistulas and grafts - FLOW
Medisch Universitair Ziekenhuis Maastricht0 sites417 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 417
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
- •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.
Outcomes
Primary Outcomes
Not specified
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