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FLOW

Flow dysfunction of hemodialysis vascular access: a randomized controlled trial on the effectiveness of surveillance of arteriovenous fistulas and grafts

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20487
Enrollment
518
Registered
2021-01-02
Start date
2021-10-07
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis vascular access

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 u

Sponsors

Maastricht University
Lead Sponsor

Eligibility

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. 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.

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 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.

Design outcomes

Primary

MeasureTime frame
Access-related intervention rate.

Secondary

MeasureTime frame
Complications, medical costs, patient-reported outcomes (SF-VAQ), and the quality of the surveillance program.

Contacts

Public ContactMaarten Snoeijs

Maastricht UMC+

maarten.snoeijs@mumc.nl0031625097694

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)