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

Recruiting

Conditions: 10003216
end-stage renal disease
Vascular access
10038430
10003184

Registration Number: NL-OMON54091

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 417

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the access-related intervention rate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are complications, medical and societal costs,<br /><br>patient-reported outcomes, and the quality of the surveillance program.</p><br>