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

Arterio-venous Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293614
• Other study ID #: DVS005
• Status: Completed
• Start date: August 14, 2019
• Est. completion date: January 14, 2023

Study information

• Verified date: March 2023
• Source: University Hospital of Limerick
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 14, 2023
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterio-venous Fistula
• Arteriovenous Fistula
• Fistula

Locations

Country	Name	City	State
Ireland	University Hospital Limerick	Limerick

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Limerick	University of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of pressure gradient within AVF on maturation and functioning of the AVF.	Pressure measurements obtained intra-operatively will be examined alongside pre and post operative ultrasound imaging of the veins and arteries.	2 years
Secondary	Comparison of in-vivo and ex-vivo perfusion with validation of CFD solutions.	The two models will be compared for validation purposes.	2 years