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Surveillance and Proactive Intervention for Dialysis Access

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.

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01391975
Acronym
SPIDA
Enrollment
0
Registered
2011-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Fistula, Renal Failure

Keywords

arteriovenous fistula, surveillance, arterial stenosis, venous stenosis

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.

Interventions

PROCEDUREActive ultrasound surveillance of fistula and proactive treatment of stenosis

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

Sponsors

University of Hull
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Incident patients referred to vascular or transplant surgery departments for primary AV fistula formation for haemodialysis access. 2. Ability to give informed written consent 3. Aged over 18 at time of referral

Exclusion criteria

1. Inability to give informed written consent 2. Aged under 18 at time of referral 3. Inability to attend follow-up appointments Specific exclusion; 1. Previous arteriovenous access procedures in target limb 2. Unsuitable for upper limb radiocephalic or brachiocephalic AVF formation 3. Known thrombophilic or thrombotic pathology

Design outcomes

Primary

MeasureTime frameDescription
Cumulative or secondary patencywithin 6 months of fistula formationThis 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

MeasureTime frame
Number of thrombosis eventswithin 6 months of fistula formation
Number of fistula failureswithin 6 months of fistula formation
Number, type and technical success rate for elective interventionswithin 6 months of fistula formation
Number, type and technical success rate of acute interventionswithin 6 months of fistula formation

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026