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WithdrawnNCT01391975SPIDAUpdated Mar 22, 2021

Surveillance and Proactive Intervention for Dialysis Access

An interventional study of Active ultrasound surveillance of fistula and proactive treatment of stenosis in Renal Failure and Arteriovenous Fistula, sponsored by University of Hull. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-22.

Sponsored by University of Hull · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Failure
  • Arteriovenous Fistula

Keywords

  • arteriovenous fistula
  • surveillance
  • arterial stenosis
  • venous stenosis
03

In context

Arteriovenous Fistula

267 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.

Browse Arteriovenous Fistula studies →

Lead sponsor

University of Hull is the lead sponsor of 33 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Surveillance and proactive intervention

    Procedure: Active ultrasound surveillance of fistula and proactive treatment of stenosis

  • No intervention
    Control and reactive intervention

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 6 months of fistula formation

Secondary outcomes

  1. Number of thrombosis events

    Time frame: within 6 months of fistula formation

  2. Number of fistula failures

    Time frame: within 6 months of fistula formation

  3. Number, type and technical success rate for elective interventions

    Time frame: within 6 months of fistula formation

  4. Number, type and technical success rate of acute interventions

    Time frame: within 6 months of fistula formation

07

Study locations

1 site
  • Hull Royal Infirmary
    Hull, HU3 2JZ, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01391975
Lead sponsor
University of Hull
Responsible party
Sponsor
First posted
Jul 12, 2011
Last update
Mar 22, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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