Invasive Arterio-Venous Fistula Blood Pressure Monitoring & Fluid Dynamics Study

NCT ID: NCT04293614

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-14
• Study Completion Date: 2023-01-14

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.

Conditions

Arterio-venous Fistula

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Limerick

OTHER

Sponsor Role: collaborator

University Hospital of Limerick

OTHER

Sponsor Role: lead

Responsible Party

Fiona Leahy

Professor Eamon Kavanagh Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eamon Kavanagh, MD FRCSI

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Limerick

Locations

University Hospital Limerick

Limerick, , Ireland

Countries

Ireland

Other Identifiers

DVS005

Identifier Type: -

Identifier Source: org_study_id