Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262659
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-05
Brief Title:
The Effect of Ultrasonography on Blood FlowVessel Diameterand Depth Measurements in Dialysis Patients With Fistula
Sponsor:
Kudret Atakan Tekin
Organization:
Hitit University
Study Overview
Official Title:
Effect Of Blood Flow Vascular Diameter And Depth Measurements With Intraoperative Doppler Ultrasonography On Arteriovenous Fistula Maturation In Dialysis Patients A Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Arteriovenous fistulas AVF are considered essential and the primary vascular access for end-stage renal disease patients to receive hemodialysis HD treatment The maturation failure rate of AVFs is approximately 23 The aim of our study is to compare intraoperative fistula flow and measurements of vascular structures diameters with postoperative fistula maturation following the completion of the fistula operation to reveal the relationship between them Providing insights into the need for intraoperative intervention andor postoperative fistula management based on these measurements is intended to contribute to the literature by offering predictions and perspectives
Detailed Description:
Arteriovenous fistulas AVF are generally acknowledged as the gold standard for hemodialysis HD access in end-stage renal disease patients While they exhibit the most successful performance their lifespan is longer compared to other access types and the infection and hospitalization rates are lower However it is known that many newly created fistulas do not mature to a level that provides sufficient HD access There is no universal definition for a matured AVF and the method adopted in the updated National Kidney Foundations Kidney Disease Outcomes Quality Initiative NKF-KDOQI guidelines is widely used KDOQI has defined the 6s rule to describe maturation a flow rate of 600 mlmin an AVF located within 6 millimeters from the skin surface to facilitate successful and repeatable cannulation by HD staff and finally a minimum diameter of 6 millimeters A matured AVF should be continuously cannulated and allow a minimum blood flow of 300-400 ml per minute Various patient factors including Diabetes Mellitus DM female gender and age have been suggested to be associated with poor AVF maturation However these factors are less important when preoperative ultrasound mapping of the relevant arterial and venous region shows vessels of sufficient size Preoperative ultrasound venous mapping has been proven to significantly assist in deciding on an AVF with a higher chance of successful maturation Surgical or endovascular intervention is frequently required for AVFs that do not mature or to facilitate maturation Even after successful AVF maturation interventions are often needed to maintain long-term patency in hemodialysis The maturation of AVF typically takes between 6 to 8 weeks Previous studies have evaluated postoperative ultrasound criteria to assess AVF maturation and determine the need for interventions that would promote maturation These studies reported high predictive values for AVF maturation using postoperative blood flow thresholds of 420-800 mlmin or diameters of 36-54 mm However the generalizability of these studies is limited due to the relatively small number of patients the prevalence of radiocephalic AVFs and variable definitions of AVF maturation While published studies have focused on the value of postoperative AVF ultrasound measurements in predicting maturation none have assessed the predictive value for determining primary patency the time until the first intervention when the AVF achieves independent maturation Venous diameter maturity is an independent determinant and a venous diameter less than 25 mm is often associated with non-maturation especially if the vein cannot expand after tourniquet application a preoperative ultrasound measurement of a vein 4 mm is expected to result in successful maturation A series of 158 patients reported that venous diameter was the main independent determinant of functional maturation and it was the only independent variable NKF-KDOQI guidelines suggest allowing a fistula to mature for at least one month before cannulation Cannulating within 14 days after AVF creation reduces long-term fistula survival and increases the risk of subsequent fistula failure by 21 times compared to fistulas cannulated after 14 days Fistulas cannulated between 15 and 28 days showed no significant difference in non-maturation rates compared to those cannulated after 43 to 84 days Ultrasound is a non-invasive imaging technology that can significantly contribute to understanding vascular anatomy in the context of dialysis access Depth measurements and flow volume detections in arterial flow in particular can guide interventions Postoperative ultrasound is commonly used to assess AVF maturation for hemodialysis
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