Renal FailureSPIDANCT01391975
Surveillance and Proactive Intervention for Dialysis Access
A study testing Active ultrasound surveillance of fistula and proactive treatment of stenosis in people with Renal Failure and Arteriovenous Fistula, run by University of Hull at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Arteriovenous Fistula
- What is being tested?
- Active ultrasound surveillance of fistula and proactive treatment of stenosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Renal Failure, Arteriovenous Fistula
- Being tested
- Active ultrasound surveillance of fistula and proactive treatment of stenosis
- Keywords
- arteriovenous fistula, surveillance, arterial stenosis, venous stenosis
- Medical subject headings
- Renal Insufficiency, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ultrasound surveillance of fistula and proactive treatment of stenosisProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Surveillance and proactive intervention | Experimental | Not described Receives: Procedure: Active ultrasound surveillance of fistula and proactive treatment of stenosis |
| Control and reactive intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 6 months of fistula formation
Secondary outcomes (4)
Number of thrombosis events
Measured: within 6 months of fistula formation
Number of fistula failures
Measured: within 6 months of fistula formation
Number, type and technical success rate for elective interventions
Measured: within 6 months of fistula formation
Number, type and technical success rate of acute interventions
Measured: within 6 months of fistula formation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391975
- Sponsor's protocol ID
- Access 6
- Acronym
- SPIDA
- Status last verified
- Mar 2021
- First submitted
- 11 Jul 2011
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01391975
- Acronym / sponsor ID
- SPIDA / Access 6
- Conditions
- Renal Failure, Arteriovenous Fistula
- Keywords
- arteriovenous fistula, surveillance, arterial stenosis, venous stenosis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surveillance and proactive intervention | Experimental | Procedure: Active ultrasound surveillance of fistula and proactive treatment of stenosis |
| Control and reactive intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active ultrasound surveillance of fistula and proactive treatment of stenosisRegular 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 | Procedure or surgery | Surveillance and proactive intervention |
Primary outcome
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.
4 secondary outcomes
Number of thrombosis events
Time frame: within 6 months of fistula formation
Number of fistula failures
Time frame: within 6 months of fistula formation
Number, type and technical success rate for elective interventions
Time frame: within 6 months of fistula formation
Number, type and technical success rate of acute interventions
Time frame: within 6 months of fistula formation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active ultrasound surveillance of fistula and proactive treatment of stenosis in people with Renal Failure and Arteriovenous Fistula, run by University of Hull at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative or secondary patency (time frame: within 6 months of fistula formation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.