Flow Dysfunction of Hemodialysis Vascular Access

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Study design: Multicenter randomized controlled trial with 417 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. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05906550
Study type	Interventional
Source	Maastricht University Medical Center
Contact	Maarten G Snoeijs, MD PhD
Phone	0031625097694
Email	maarten.snoeijs@mumc.nl
Status	Recruiting
Phase	N/A
Start date	November 1, 2021
Completion date	September 30, 2025

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Flow Dysfunction of Hemodialysis Vascular Access — FLOW

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms