SONAR
Chief investigator: Mr Gavin Pettigrew
Primary sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Funder: NIHR Health Technology Assessment Board
Summary
A prospective observational cohort study to determine whether ultrasound surveillance can reliably predict arteriovenous fistulae (AVF) failure in patients with chronic kidney disease.
Study hypothesis
The overall aim of this programme of research is to determine whether ultrasound surveillance of newly-formed AVFs can be used to identify failing fistulas and subsequent salvage intervention can be then used to maintain patency. We feel that for a trial to demonstrate that ultrasound surveillance improves patency rates for newly created fistula, two conditions must be met: 1. Ultrasound can effectively distinguish those newly-formed fistulas that are unlikely to mature 2. Salvage interventions performed on those ‘at-risk’ fistulas are effective.
Study design
The Phase 1 trial will recruit patients who are either pre-dialysis or already established on haemodialysis via a central venous catheter. Consenting patients will undergo serial ultrasound scanning at weeks 2, 4, 6 and 10 after fistula formation in addition to standard care (such as regular clinical assessment) as per local centre policy. The ultrasound findings will be blinded, i.e. not be relayed to the participant or to the participant’s clinical team.