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

NCT04293614 | Completed

• 1 other identifier: DVS005
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterio-venous Fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of in-vivo and ex-vivo perfusion with validation of CFD solutions.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Limerick: lead
• University of Limerick: collaborator

Study Sites (1)

University Hospital Limerick

Limerick, V94 F858, Ireland

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Eamon Kavanagh, MD FRCSI

  University Hospital of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Eamon Kavanagh Prinicipal Investigator

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: August 14, 2019
• Primary Completion: December 14, 2022
• Study Completion: January 14, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IE (1)