Surveillance and Proactive Intervention for Dialysis Access

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Renal Failure, Arteriovenous Fistula

Intervention / Treatment
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* Procedure: Active ultrasound surveillance of fistula and proactive treatment of stenosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surveillance and proactive intervention<br> | Procedure: Active ultrasound surveillance of fistula and proactive treatment of stenosis<br>* Regular duplex ultrasound assessment of fistula from time of creation until 6 months post procedure with referral of all haemodynamically significant stenoses to further imaging and treatment<br>|
| No Intervention: Control and reactive intervention<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative or secondary patency | 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. | within 6 months of fistula formation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of thrombosis events |  | within 6 months of fistula formation | 
| 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, type and technical success rate of acute interventions |  | within 6 months of fistula formation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arteriovenous fistula, surveillance, arterial stenosis, venous stenosis