Arteriovenous fistula in patients with established or approaching end stage renal disease (ESRD) requiring dialysis Urological and Genital Diseases Arteriovenous fistula in patients with established or approaching end stage renal disease (ESRD) requiring dialysis
Conditions
Interventions
Consenting participants who are enrolled will be observed for 10 weeks following creation of their AV fistula and will undergo Doppler ultrasound scans during weeks 2, 4, 6 and 10. Routine clinical e
Sponsors
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary fistula patency at week 10, according to surrogate ultrasound parameters. This is assessed using venous diameter and blood flow measurements: 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 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Successful use of the fistula for those patients established on dialysis, determined by its use for dialysis on 3 separate occasions during the 10 weeks after the arteriovenous fistula (AVF) surgical creation 2. Clinical suitability for dialysis based on examination alone according to local practice, assessed 10 weeks after AVF surgical creation 3. Formation of a new fistula (including fashioning of proximal neoanastomosis) or radiological salvage procedure, measured by collecting the number and type of these interventions during the 10 weeks after AVF surgical creation 4. Fistula thrombosis, measured by collecting the number of fistulae that fully thrombose during the 10 weeks after surgical creation 5. Secondary fistula patency, measured by the time interval (in days) between AVF creation until abandoment of the AVF including all radiological and surgical salvage procedures in between, during the 10 weeks after AVF surgical creation 6. Patient acceptability based on the proportion of patients that complete their study ultrasound scans 10 weeks after AVF surgical creation | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactAnna Sidders
Outcome results
None listed