Ultrasound Prediction of Successful Balloon Assisted AVF Maturation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: Immature AVF (requiring BAM)

Trial outcomes

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.

Time frame
6 weeks post BAM

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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