End Stage Renal Failure, Surgery
Conditions
Keywords
fistula, ultrasound, angioaccess, preoperative vein mapping, Haemodialysis, Angioaccess surgery
Brief summary
Dialysis patients have their blood filtered by a machine as their kidneys no longer work. To get blood in and out of these patients it is possible to perform a surgical procedure to increase to size and durability of a vein in the arm to allow repeated needle insertion. This enlarged vein is called a fistula. There is some evidence that ultrasound scanning the blood vessels in the arm before surgery can improve the chances of a successful procedure. The investigators aim to test whether scanning all patients is better than scanning only those who are difficult to assess by physical examination alone.
Detailed description
We will recruit all patients undergoing primary vascular access procedures in our unit who meet inclusion criteria. They will be randomised to either surgery based on clinical findings with duplex ultrasound only if requested by surgeon, or routine duplex ultrasound prior to surgery.
Interventions
PROCEDUREArterial and venous duplex ultrasound examination
Ultrasound mapping of all blood vessels in the upper limb of interest
Sponsors
University of Hull
Hull University Teaching Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Specific inclusion criteria necessary for invitation to study participation; Patients referred to vascular consultants for primary AV fistula formation (or primary fistula in that limb) for haemodialysis access. General inclusion criteria; * Ability to give informed written consent
Exclusion criteria
* Specific
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary failure of access (immediate/early thrombosis or failure to mature). | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Assisted primary patency - being the interval from placement until the time of measurement of patency, including intervening manipulations | open ended |
| Secondary patency - The interval from placement until time of patency measurement including intervening manipulations | open ended |
| Site of fistula created | within 1 month of recruitment |
| Functional primary patency - being the interval from the time of access placement until any intervention designed to maintain or re-establish patency or the time of measurement of patency during which the AVF provides dialysis access. | open ended |
| Surgeon grade | open ended |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microparticle concentration | open | Blood tests will be taken at baseline, 1, 3 and 6 months to investigate the impact of concentrations on patency |
| Circulating tissue factor concentration | open | Blood test to be taken at baseline, 1, 3 and 6 months and examined using ELISA to establish the impact of tissue factor concentrations on patency |
Countries
United Kingdom
Outcome results
None listed