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Flow Dysfunction of Hemodialysis Vascular Access

NCT05906550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2026-02-05

No results posted yet for this study

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.

Conditions

  • Dialysis Access Malfunction
  • Hemodialysis Access Failure
  • Hemodialysis Fistula Thrombosis
  • Vascular Access Malfunction

Interventions

DIAGNOSTIC_TEST

Vascular access monitoring

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. Patients will be referred for correction of the underlying stenosis when clinical signs of flow dysfunction are present.

DIAGNOSTIC_TEST

Vascular access blood flow measurement

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.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Maarten G Snoeijs, MD PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05906550 on ClinicalTrials.gov