A Multi Centre Randomized Controlled Trial of the Clinical and Cost Effectiveness of Duplex Ultrasound Surveillance With Proactive Intervention Versus no Surveillance and Reactive Intervention for the Management of Stenosis in Arterio-venous Fistulae for Dialysis Vascular Access.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Failure
- Sponsor
- University of Hull
- Locations
- 1
- Primary Endpoint
- Cumulative or secondary patency
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
Newly formed dialysis fistulae can often fail, and failure is usually due to narrowing of the blood vessels. Methods of detecting narrowing are available and, more importantly, can detect narrowings before a fistula fails. It is not known whether treating these narrowings will actually improve fistula survival or if the majority can be left alone. we wish to see if we can detect such narrowings with ultrasound scanning and if early detection and treatment improves patient outcomes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Incident patients referred to vascular or transplant surgery departments for primary AV fistula formation for haemodialysis access.
- •Ability to give informed written consent
- •Aged over 18 at time of referral
Exclusion Criteria
- •Inability to give informed written consent
- •Aged under 18 at time of referral
- •Inability to attend follow-up appointments
- •Specific exclusion;
- •Previous arteriovenous access procedures in target limb
- •Unsuitable for upper limb radiocephalic or brachiocephalic AVF formation
- •Known thrombophilic or thrombotic pathology
Outcomes
Primary Outcomes
Cumulative or secondary patency
Time Frame: within 6 months of fistula formation
This being the interval from the time of access placement until access abandonment, thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access.
Secondary Outcomes
- Number of fistula failures(within 6 months of fistula formation)
- Number, type and technical success rate for elective interventions(within 6 months of fistula formation)
- Number of thrombosis events(within 6 months of fistula formation)
- Number, type and technical success rate of acute interventions(within 6 months of fistula formation)