SONAR: Surveillance Of arterioveNous fistulAe using ultRasound

Not Applicable

Completed

• Conditions: Arteriovenous fistula in patients with established or approaching end stage renal disease (ESRD) requiring dialysis; Urological and Genital Diseases

• Registration Number: ISRCTN36033877
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31340975/ protocol (added 07/08/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33796281/ (added 21/09/2023) 2024 Results article in https://doi.org/10.1016/j.ekir.2024.01.011 (added 25/04/2024) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38768043/ (added 22/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-09
• Study Completion: 2020-01-31
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

1. Aged 16 years or older
2. End stage renal disease
3. Requires haemodialysis or is likely to do so immediately
4. Due creation of an arm arteriovenous fistula (wrist or elbow), including the following types of fistula with a minimal acceptable threshold of 2 mm venous diameter at whatever site chosen:
4.1. Radiocephalic
4.2. Ulno-basilic
4.3. Brachiocephalic
4.4. Brachiobasilic
5. Provides fully informed consent

Exclusion Criteria

1. Attempted formation of proximal neo-anastomosis at the forearm cephalic and basilic venous systems following failure of a standard radiocephalic or ulnobasilic fistula
2. Known central venous stenosis (including those who undergo simultaneous central venous angioplasty / stenting and arteriovenous fistula creation)
3. Anticipated that it will not be possible to perform serial ultrasound scanning

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary fistula patency at week 10, according to surrogate ultrasound parameters. This is assessed using venous diameter and blood flow measurements:<br>1. Wrist fistula, considered to be patent if there is a minimum venous diameter of 4 mm with a blood flow measurement of > 400 ml/min<br>2. Elbow fistula, considered to be patent if there is a minimum venous fistula diameter of 5 mm, with a blood flow measurement of > 500 ml/min