Advanced Ultrasound Applications for Predicting AVF Outcomes

NCT04141358 | Completed

• 1 other identifier: 19HH5550
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Diseases; Renal Failure; Chronic Kidney Diseases

Keywords

Vascular Access; Endothelial Dysfunction; Vascular Stiffness; Arteriovenous Fistula

Outcome Measures

Primary Outcomes (2)

• Patency of arteriovenous fistula according to ultrasound parameters

  Rate of blood volume flow \>400 mL/min.

  6 Weeks

• Arteriovenous fistula diameter

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

  6 Weeks

Secondary Outcomes (1)

• Number of arteriovenous fistula successful use for haemodialysis.

  10 weeks

Study Arms (1)

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

Interventions

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

Study group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, w12 0hs, United Kingdom

Location

Related Publications (3)

• Kheda MF, Brenner LE, Patel MJ, Wynn JJ, White JJ, Prisant LM, Jones SA, Paulson WD. Influence of arterial elasticity and vessel dilatation on arteriovenous fistula maturation: a prospective cohort study. Nephrol Dial Transplant. 2010 Feb;25(2):525-31. doi: 10.1093/ndt/gfp462. Epub 2009 Sep 15.

  PMID: 19755475 BACKGROUND

• McGrogan DG, Maxwell AP, Khawaja AZ, Inston NG. Current tools for prediction of arteriovenous fistula outcomes. Clin Kidney J. 2015 Jun;8(3):282-9. doi: 10.1093/ckj/sfv019. Epub 2015 Apr 2.

  PMID: 26034589 BACKGROUND

• Owens CD, Wake N, Kim JM, Hentschel D, Conte MS, Schanzer A. Endothelial function predicts positive arterial-venous fistula remodeling in subjects with stage IV and V chronic kidney disease. J Vasc Access. 2010 Oct-Dec;11(4):329-34. doi: 10.5301/jva.2010.5833.

  PMID: 21038305 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

The leftover vessel specimens will be collected at the AVF surgery and placed immediately in a suitable biopsy container with formalin to prevent specimen drying. To study pre-existing diseases.

MeSH Terms

Conditions

Renal Insufficiency; Renal Insufficiency, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Study Officials

• Mohammed Aslam, PhD

  Academic Supervisor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 28, 2019
• Study Start: November 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)