Ultrasound Prediction of Successful Balloon Assisted AVF Maturation

NCT06771973 | Not Yet Recruiting

• 1 other identifier: 24/YH/0247
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

An arteriovenous fistula (AVF) is created to allow for cleaning of the blood in patients with severe kidney disease. An artery and a vein are surgically connected, typically in the arm. This connection changes how the blood flows through the vessels, creating much higher flow in the arm vein than before the operation. Higher blood flow enables blood flow to be cleaned externally with a machine replacing the function of the kidneys. This process is known as dialysis. However, a period known as maturation is required before an AVF can be used in this way. During this time, the vessels grow in size and blood flow continues to increase. In some cases this does not happen and a procedure is required to help the AVF to mature. AVFs not likely to mature may undergo a procedure, known as balloon assisted maturation (BAM), in which a balloon on the end of a catheter is inserted into the AVF vein and inflated. This is typically needed if an AVF is not likely to develop in a way that can be used for dialysis. Blood cleaning, or haemodialysis, is vital in patients with end stage renal disease, or kidney failure. Blood flow measurement using ultrasound, and routine blood test results, may help us predict which AVFs will respond better to BAM. Ultrasound can be used in the clinic setting and can provide the consultants responsible for the patients ongoing management with information that can enable decisions to be made at an early opportunity, and allowing the participants to be involved in future management decisions. This study aims to identify features of the blood flow following the BAM procedure that might be used to predict if the AVF will successfully mature.

Conditions

End Stage Renal Disease (ESRD); Chronic Kidney Disease Requiring Hemodialysis

Keywords

arteriovenous fistula; AVF; CKD; ESRD

Outcome Measures

Primary Outcomes (1)

• Successful AVF maturation at time of routine clinic appointment at 6 weeks post BAM procedure

  Hybrid radiographic and clinical approach, namely a volume flow rate of ≥600ml/min, fistula vein diameter of ≥6mm combined with suitability for haemodialysis use as determined by clinician review. Failure to meet either criteria will be defined as failure to mature.

  6 weeks post BAM

Study Arms (1)

Immature AVF (requiring BAM)

Cohort to undergo BAM procedure. No additional interventions required.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with ESRD with immature AVFs requiring balloon assisted maturation procedures will be recruited from renal access clinics in a hospital setting

You may qualify if:

• Adult patients (\>18 years of age) referred for BAM procedure due to immature native AVF
• AVFs with radio-cephalic or brachio-cephalic configuration
• AVF suitable for endovascular BAM procedure
• Patient is able to provide informed consent
• Patient is willing and able to comply with the study-related procedures

You may not qualify if:

• Brachio-basilic AVFs requiring transposition and superficialisation procedures during maturation phase
• Patients with arterio-venous grafts (AVGs) for vascular access
• Previous BAM procedures performed to facilitate maturation
• AVF unsuitable for BAM procedure or BAM procedure not performed

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; 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

Central Study Contacts

Luke H Smith, MSc

CONTACT

+442071886778; luke.smith1@gstt.nhs.uk

Soundrie Padayachee, PhD

CONTACT

+442071886778; soundrie.padayachee@gstt.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: January 13, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share