Advanced Ultrasound Applications for Predicting AVF Outcomes (AUAPAVFO)

October 6, 2023 updated by: Imperial College London

Using Ultrasound 2D Strain Speckle Tracking, 2D Shear Wave Elastography and Transonic Flowmeter as Diagnostic and Potential Predictor Tool for Arteriovenous Fistula Outcomes With End Stage Renal Failure.

Haemodialysis is a renal replacement therapy that can be introduced to patients with end-stage renal disease (ESRD) to help them maintain a good healthy life. The patient's blood is pumped through a dialysis machine to remove excess fluid, salt and waste, then it is pumped back into the patient's circulation system. In order to carry out haemodialysis, vascular access (VA) is required to connect the patient to the dialysis machine. Patients have only three options of vascular access: arteriovenous fistula (AVF), an anastomosis between a native vein and an artery; arteriovenous graft (AVG), a connection between a synthetic tube and native blood vessels; and (3) central line, a cuffed catheter placed in a large neck vein. Arteriovenous fistulas are the preferred method for VA because of their longevity and causing the least number of complications. Although there are a number of factors that may increase the probability of AVF failure rate such as age and gender of the patient, poor native vessel structure, medications and the level of surgical experience, 30-40% of new AVFs fail to mature for unknown reasons. For an AVF to become functionally mature postoperative, remodelling and dilation of the native artery and vein are essential to accommodate significantly increased blood flow. However, pre-existing diseases in patients with ESRD such as arterial stiffness and endothelial dysfunction may impair AVF and preclude dialysis. It has been asserted that the lack of AVF success is attributable to insufficient arterial dilation because of poor arterial wall elasticity.

The study aims to investigate the role of arterial stiffness and endothelial dysfunction in predicting AVF outcome using novel non-invasive ultrasound applications: 2D shear wave elastography and 2D strain speckle tracking will be employed to assess arterial stiffness, while an intraoperative flow-mediated dilation (FMD) technique will be used to evaluate endothelial dysfunction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an observational prospective pilot study of patients with end-stage renal disease (ESRD), who will be referred for AVF procedure.

Duration: 21 Months The research team will collect data from the patients after they have signed the informed consent form. Data collection will take place before, during and after arteriovenous fistula (AVF) surgery.

At 0 week, the patient will be interviewed to obtain clinical information. Also, blood pressure and body mass index will be checked and recorded. Next, pre-operative AVF assessment ultrasound measurements will be performed to assess flow, pulsatility and vessel diameter. Advanced ultrasound applications(2D strain speckle tracking and 2D Shear wave elastography) will be applied to assess arterial stiffness as additional measurement tools. These are quantitative measures of vessel stiffness. It takes less than five minutes to obtain these measurements from the imaged vessel.

During AVF surgery, the endothelial function will be assessed intraoperatively by testing the ability of the endothelium to dilate, flow mediation dilation (FMD). Leftover vessel specimens will be collected for histopathological analysis purpose.

At 6 week, post-AVF ultrasound assessment will be conducted to assess the maturation of AVF by measuring ultrasound parameters of blood flow, pulsatility and vessel diameter. Arterial stiffness parameters will be measured as well. Blood pressure and BMI will be assessed and recorded.

Study data will be entered into a study database which will consist of a password encrypted stored on a password-protected computer in the vascular lab at Hammersmith Hospital. Only the study researchers will know the study database password.

Data analysis will be performed after the enrolment of 20, 40 and 75 patients.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients selected for this protocol must have the necessity to undergo surgery to receive an Arterio-Venos Fistula (AVF) for hemodialysis in either arm.

Description

Inclusion Criteria:

  • >18 years age
  • <90 years age
  • End stage renal disease
  • Glomerular filtration rate < 30 ml/min/1.73m2

Exclusion Criteria:

  • <18 years age
  • > 90 years age
  • < 2cm vein diameter
  • Not end-stage renal disease
  • Pregnant patients will not be recruited in this study. Patients pregnancy status will be assessed on initial enrolment to exclude them from the study.
  • Those unable to provide consent.
  • Anyone who is taking part in any other research.
  • Potential participants who might not adequately understand verbal explanations or written information given in English, or who have special communication needs will not be included

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Patients with end-stage renal disease who will undergo arteriovenous fistula (AVF) surgery will be recruited and follow-up them up to 6 weeks or until the AVF become suitable for hemodialysis.
Diagnostic test: Advanced ultrasound measurements

Clinical interventions and procedures:

  • Consent at 0 week
  • Clinical data collection at 0 week
  • Strain for native artery at 0 week
  • Young's modulus for native artery at 0 week
  • Intimal medial thickness for native artery at 0 week
  • Ultrasound blood volume flow measurement at 0 week
  • Vessel diameter at 0 week
  • Blood pressure at 0 week
  • BMI at 0 week
  • Intra-operative blood volume flow measurement at AVF surgery time
  • Strain for native artery at 6 weeks
  • Young's modulus native artery at 6 weeks
  • Intimal medial thickness native artery arteries at 6 weeks
  • Ultrasound blood volume flow measurement at 6 weeks
  • Vessel diameter at 6 weeks
  • Blood pressure at 6 weeks
  • BMI at 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patency of arteriovenous fistula according to ultrasound parameters
Time Frame: 6 Weeks
Rate of blood volume flow >400 mL/min.
6 Weeks
Arteriovenous fistula diameter
Time Frame: 6 Weeks
Fistula considered to be patent if there is a minimum venous diameter of ≥ 5 mm.
6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of arteriovenous fistula successful use for haemodialysis.
Time Frame: 10 weeks
≥ 3 uses on separate occasions post-arteriovenous fistula surgery.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Study Director: Mohammed Aslam, PhD, Academic Supervisor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 28, 2019

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19HH5550

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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