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Ultrasound Prediction of Successful Balloon Assisted AVF Maturation

NCT06771973 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-01-15

No results posted yet for this study

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

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2026-03-01
Completion
2026-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06771973 on ClinicalTrials.gov