Flow Dysfunction of Hemodialysis Vascular Access (FLOW)

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Dialysis Access Malfunction; Hemodialysis Fistula Thrombosis; Vascular Access Malfunction; Hemodialysis Access Failure

Treatments: Diagnostic Test: Vascular access blood flow measurement; Diagnostic Test: Vascular access monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05906550

NL75845.068.20

NL9165 (Registry Identifier)

Details and patient eligibility

About

The FLOW trial evaluates the follow-up of the vascular access for hemodialysis. In current clinical care, vascular access flow volume is periodically assessed to detect and treat asymptomatic stenosis. The FLOW trial will determine whether it is safe to abandon this practice of active surveillance. Vascular access stenosis will then be treated only when clinical problems of flow dysfunction occur during hemodialysis. The investigators expect that the intervention rate and medical costs will be reduced by 40% when correction of vascular access stenosis is triggered by clinically apparent access dysfunction rather than asymptomatic flow reduction.

Full description

Study design: Multicenter randomized controlled trial with 375 patients. Patients will be followed up for 2 to 3 years. The trial is powered to detect a reduction in the intervention rate of 0.25 per year between study groups in a superiority analysis (this is associated with cost savings of 1 million euros per year in the Netherlands). Subgroup analyses of arteriovenous fistulas and grafts and of successful and failed interventions will be done.

On 25-02-2025, the sample size was reduced from 417 to 375 patients because updated calculations based on actual event and loss to follow-up rates in the trial population showed sufficient power to detect the prespecified clinically relevant difference.

Study population: Chronic hemodialysis patients with a functioning arteriovenous fistula or graft.

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 unexplained, sustained fall in dialysis adequacy.

Control group: Monthly surveillance of vascular access blood flow volume by ultrasound dilution measurements during hemodialysis sessions. Patients will be referred for correction of the underlying stenosis at an access flow volume <500mL/min, or when clinical signs of flow dysfunction are present.

Enrollment: 375 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

   1. Vascular access flow volume of at least 500mL/min; and
   2. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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375 participants in 2 patient groups

Intervention group

Experimental group

Description:

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 unexplained, sustained fall in dialysis adequacy.

Treatment:

Diagnostic Test: Vascular access monitoring

Control group

Active Comparator group

Description:

Monthly surveillance of vascular access blood flow volume by ultrasound dilution measurements during hemodialysis sessions. Patients will be referred for correction of the underlying stenosis at an access flow volume \<500mL/min, or when clinical signs of flow dysfunction are present.

Treatment:

Diagnostic Test: Vascular access monitoring

Diagnostic Test: Vascular access blood flow measurement