Flow Dysfunction of Hemodialysis Vascular Access: a Randomized Controlled Trial on the Effectiveness of Surveillance of Arteriovenous Fistulas and Grafts
Overview
- Phase
- N/A
- Intervention
- Vascular access monitoring
- Conditions
- Dialysis Access Malfunction
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 375
- Locations
- 13
- Primary Endpoint
- Access-related intervention rate
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients aged 18 years or older.
- •End-stage renal disease with unlikely recovery of kidney function according to the attending nephrologist.
- •Arteriovenous fistula or arteriovenous graft as hemodialysis vascular access that fulfills both of the following criteria at the time of trial enrollment:
- •Vascular access flow volume of at least 500mL/min; and
- •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.
- •Planning to remain in one of the participating dialysis centers for at least 1 year.
Exclusion Criteria
- •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).
- •Home hemodialysis.
- •Thrombosis of the current vascular access in the past year.
- •Planned access-related intervention.
- •Living donor kidney transplantation, switch to peritoneal dialysis, or switch to home hemodialysis planned within 6 months.
- •Life expectancy of less than 6 months, in the opinion of the attending nephrologist.
- •Unable to provide informed consent.
Arms & 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 unexplained, sustained fall in dialysis adequacy.
Intervention: Vascular access monitoring
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.
Intervention: Vascular access monitoring
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.
Intervention: Vascular access blood flow measurement
Outcomes
Primary Outcomes
Access-related intervention rate
Time Frame: Variable follow-up time of 2-3 years
The number of interventions required for each patient-year of hemodialysis treatment
Secondary Outcomes
- Access-related complications per patient-year (2)(Variable follow-up time of 2-3 years)
- All-cause mortality(Variable follow-up time of 2-3 years)
- Access-related health care costs (1)(Every 3 months for 2-3 years from randomization (variable follow-up time))
- Access-related complications per patient-year (1)(Variable follow-up time of 2-3 years)
- Access-related health care costs (2)(Every 3 months for 2-3 years from randomization (variable follow-up time))
- Quality of the surveillance program (3)(Variable follow-up time of 2-3 years)
- Patient-reported outcome measures (1)(Every 3 months for 2-3 years from randomization (variable follow-up time))
- Patient-reported outcome measures (2)(Every 3 months for 2-3 years from randomization (variable follow-up time))
- Quality of the surveillance program (1)(Variable follow-up time of 2-3 years)
- Primary patency(Variable follow-up time of 2-3 years)
- Secondary patency(Variable follow-up time of 2-3 years)
- The number of hemodialysis sessions with cannulation difficulties(Variable follow-up time of 2-3 years)
- Quality of the surveillance program (2)(Variable follow-up time of 2-3 years)
- Quality of the surveillance program (4)(Variable follow-up time of 2-3 years)
- Assisted primary patency(Variable follow-up time of 2-3 years)