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Clinical Trials/NL-OMON20487
NL-OMON20487
Recruiting
N/A

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

Maastricht University0 sites518 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Maastricht University
Enrollment
518
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

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. 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

  • 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.

Outcomes

Primary Outcomes

Not specified

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