Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04293614
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2020-02-28
Brief Title:
Invasive Arterio-Venous Fistula Blood Pressure Monitoring Fluid Dynamics Study
Sponsor:
University Hospital of Limerick
Organization:
University Hospital of Limerick
Study Overview
Official Title:
Invasive Arterio-Venous Fistula Blood Pressure Monitoring Fluid Dynamics Study
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 AVFs 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
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 AVFs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None