Randomized-controlled clinical trial for the evaluation of the efficacy of computational simulation for the planning of vascular access surgery in hemodialysis patients

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 fistel (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.

To evaluate the efficacy of computational simulation for the planning of
vascular access surgery in hemodialysis patients.

Randomized-controlled clinical trial. In the intervention group the vascular
surgeon receives an overview of relevant patient characteristics (including
duplex measurements) and an advice which AVF-configuration (fore- or upper arm)
is indicated. In the control group, the vascular surgeon only receives the
overview.

Randomization for the type of surgical vascular access creation (fore- or upper
arm AVF).

Additional burden for this study is approximately one hour. This hour consists
of additional non-invasive duplex measurements, necessary for reliable
predictions by the computational tool. It is, however, possible that local
preoperative duplex protocol already contains these measurements. Then the
burden is practically absent.
Based on previous research there are no expected risks that are directly
related to the computational tool.