We expect that the access-related 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 by asymptomatic flow reduction detected by…
ID
Bron
Verkorte titel
Aandoening
Hemodialysis vascular access
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Access-related intervention rate.
Achtergrond van het onderzoek
The FLOW project 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 project 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.
Doel van het onderzoek
We expect that the access-related 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 by asymptomatic flow reduction detected by surveillance. This would amount to cost savings of 3.0 million euros per year in the Netherlands.
We expect that the rate of access thrombosis will increase no more than 0.5 events per patient-year when correction of vascular access stenosis is triggered by clinically apparent access dysfunction rather than by asymptomatic flow reduction detected by surveillance.
Onderzoeksopzet
Patients will be followed up for 2 years for the primary outcome and secondary outcomes. Access-related interventions and complications will be registered prospectively during this time period. Medical costs and patient-reported outcomes will be measured with questionnaires every 3 months. The quality of the surveillance program will be evaluated using data accumulated over the 2-year study period.
Onderzoeksproduct en/of interventie
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.
Comparison 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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL9165 |
Ander register | METC azM/UM : METC 21-004 |