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NCT Number: NCT04141358

Advanced Ultrasound Applications for Predicting AVF Outcomes

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.

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Key information

Conditions

End Stage Renal Diseases Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Failure Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College London

London, w12 0hs, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advanced ultrasound measurements

Diagnostic Test

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

Primary outcomes

  1. Patency of arteriovenous fistula according to ultrasound parameters

    Time frame: 6 Weeks

    Rate of blood volume flow >400 mL/min.

  2. Arteriovenous fistula diameter

    Time frame: 6 Weeks

    Fistula considered to be patent if there is a minimum venous diameter of ≥ 5 mm.

Secondary outcomes

  1. Number of arteriovenous fistula successful use for haemodialysis.

    Time frame: 10 weeks

    ≥ 3 uses on separate occasions post-arteriovenous fistula surgery.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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.

Acronym: AUAPAVFO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2019
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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