Preoperative Arteriovenous Fistula Simulation Study (ShuntSimulationStudy)

Summary

Patients suffering from end-stage renal disease (ESRD) are dependent on renal replacement therapy (dialysis). The majority of dialysis is facilitated by hemodialysis. For hemodialysis a vascular access is necessary, preferable an arteriovenous fistula (AVF) in which a vein is directly anastomosed to an artery. In order to use the AVF for hemodialysis three criteria have to be met; the minimal flow over the AVF is 600 mL/min, the diameter is at least 6 mm, and the AVF is located less than 6 mm under the skin. Unfortunately, approximately half of the patients (50%) are confronted with an AVF that does not meet these criteria; the so called non-maturation or primary failure. In case of non-maturation the AVF is not only unusable for dialysis, but also requires reinterventions on short- and long-term. Firstly to mature the AVF, and secondly, when the AVF is matured, to keep the vascular access. Using a computational simulation postoperative flow can be predicted. Based on patient-specific duplex measurements, the model can calculate the flow that can be expected following vascular access surgery for all AVF configurations; fore- or upper arm. These calculations lead to an advice which configuration is indicated; a flow that exceeds 600 mL/min, leading to maturation. Potentially the aforementioned 50% of non-maturation can be reduced. The patient then has an adequate vascular access and reinterventions are adverted, resulting in a decrease of costs, hospital demand, and an increase of the patients' quality of life. When the expected reduction of non-maturation is confirmed, the computational tool can be offered to other hospitals.

Conditions

• Kidney Failure, Chronic
• Arteriovenous Fistulae

Interventions

DEVICE

AVF-simulation

A mathematical computational tool, which is developed to calculate estimates for postoperative AVF hemodynamical changes in the upper extremity. The model is based on physical laws and calculations are carried out on patient-specific duplex measurements.

Sponsors & Collaborators

• Maastricht University

  collaborator OTHER

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Niek Zonnebeld, MD · Maastricht University Medical Center

• Jan Tordoir, MD, PhD · Maastricht University Medical Center

• Wouter Huberts, PhD · Maastricht University Medical Center

• Tammo Delhaas, MD, PhD · Maastricht University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2018-07-31

Completion

2019-06-30

Countries

• Netherlands

Study Locations