Clinical trial NCT04293614: Invasive Arterio-Venous Fistula Blood Pressure Monitoring & Fluid Dynamics Study
Official title: Invasive Arterio-Venous Fistula Blood Pressure Monitoring & Fluid Dynamics Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterio-venous Fistula
Lead sponsor: University Hospital of Limerick
Sponsor class: OTHER
Collaborators: name: University of Limerick
First posted: 2020-03-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of individuals with ESRD who are undergoing AVF creation or intervention surgery for the purpose of undergoing Haemodialysis treatment.

Brief summary: The surgical formation of an AVF offers a unique example of vascular remodelling and adaption. Yet, the specific factors which elicit remodelling events which determine successful maturation or failure have not been unambiguously determined.

Computational fluid dynamic (CFD) simulations are increasingly been employed to investigate the interaction between local haemodynamics and remodelling and can potentially be used to assist in clinical risk assessment of maturation or failure.

However, these simulations are inextricably linked to their prescribed boundary conditions and are reliant on in vivo measurements of flow and pressure to ensure their validity. This study will compare in vivo measurements of the pressure distribution across an AVF against a representative numerical model.

Detailed description: Most patients with End Stage Renal Disease (ESRD) will require haemodialysis. Several studies have recognized a well-functioning Arterio-Venous Fistula (AVF) as the best modality for access in patients with ESRD undergoing haemodialysis.

A mature AVF has lower incidence of thrombosis and stenosis compared to the other two available modalities of the Arterio-Venous Graft (AVG) and Central Venous Catheter (CVC). This translates into prolonged patency rates and lower risk of infection. The use of AVF's are also associated with lower mortality, and costs.

However, significant numbers of AVFs \[20% to 60 %\] are known to fail to mature into functioning fistulas. Issues such as impaired vein remodelling, intimal hyperplasia, technical problems, unrecognized stenosis within the outflow vein, inflow problems, or steal syndromes can all lead to failure of achieving a mature AVF.

The aim of the study is to examine the relationship between the pressure gradient within the surgically formed AVF and its' maturation and functioning status.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing AVF formation surgical procedure or AVF intervention surgery.
2. Willing and capable of signing an informed consent form.

Exclusion Criteria:

1. Patients unable to provide informed consent.
2. Patients under the age of 18
3. Patients who are deemed unsuitable due to any circumstances as deemed appropriate by the P.I.

Primary outcomes:
measure: Effects of pressure gradient within AVF on maturation and functioning of the AVF.
timeFrame: 2 years
Secondary outcomes:
measure: Comparison of in-vivo and ex-vivo perfusion with validation of CFD solutions.
timeFrame: 2 years
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University Hospital Limerick
Study officials:
affiliation: University Hospital of Limerick
name: Eamon Kavanagh, MD FRCSI
role: PRINCIPAL_INVESTIGATOR
References: