Arteriovenous FistulasSTEALNCT02297451
Trial Comparing the Incidence of Steal Syndrome in the Two Types of anTEcubitaL Fossa Arteriovenous fistuLa AVF
A study testing Proximal radial/ulnar artery as inflow in people with Arteriovenous Fistulas and Renal Failure, End-Stage, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Background: Arteriovenous fistula (AVF) is a form of vascular access for haemodialysis. An AVF is normally created at the level of the wrist, but occasionally it is created in the elbow when there is no suitable vessel in the forearm. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Arteriovenous Fistulas, Renal Failure, End-Stage, Steal Syndrome
- What is being tested?
- Proximal radial/ulnar artery as inflow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Dec 2018
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- End stage renal failure Requiring AVF at in the antecubital fossa for haemodialysis
Who cannot join
- When the participant has not received the allocated intervention due to anatomical anomaly, technical issue or any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial Comparing the Incidence of Steal Syndrome in the Two Types of anTEcubitaL Fossa Arteriovenous fistuLa AVF (STEAL Trial)
Background:
Arteriovenous fistula (AVF) is a form of vascular access for haemodialysis. An AVF is normally created at the level of the wrist, but occasionally it is created in the elbow when there is no suitable vessel in the forearm. The most common type of elbow (antecubital) fistula (AFF) is a brachiocephalic fistula, which carries significantly higher risk of steal syndrome (AVF-associated hand ischaemia) than wrist fistulas. More recently, AFF using proximal radial or ulnar artery as inflow has been described and shown to have a lower rate of Steal syndrome than brachiocephalic fistula. This study aims to investigate the incidence of steal syndrome between AFF using brachial artery and that using the proximal radial/ulnar artery as inflow.
Read the detailed description
Arteriovenous fistulas (AVF) are the safest form of vascular access for long-term haemodialysis in patients with end-stage renal failure. The strategy in creating an AVF in the upper limbs is to start at a distal site and if that fails, to attempt an AVF on a more proximal site i.e. from wrist, forearm to elbow. The most common type of AVF is the radiocephalic AVF at the wrist. A more proximal AVF is often created as a primary procedure when there is poor vasculature in the distal forearm or as a secondary procedure when a wrist fistula has failed. Traditionally, brachiocephalic fistulas (BCF), which involves anastomosing the cephalic vein to the brachial artery, have been the most common type of AVF created in the antecubital fossa at the elbow level. Other common types of antecubital fossa arteriovenous fistula (AFF) are the brachiobasilic (BBF) and brachio-median cubital AVF.
Steal syndrome relates to hand ischaemia associated with AVF creation, and is a major risk of AVF formation. The symptoms of steal syndrome ranges from cold extremities, numbness, hand claudication (pain after exercise), to rest pain and tissue loss. Steal syndrome can also be measured by Digital Brachial Pressure Index. Severe steal syndrome is debilitating, and limb-threatening, and requires surgical revision or ligation of the AVF. This leads to additional surgical risks and loss of dialysis vascular access.
Diabetes and the types of AVF have been found to be independent risk factors for developing steal syndrome following AVF creation1. The highest risk is seen in patients with a proximal AVF i.e. BCF/BBF; up to 50% of patients in some studies, compared to 5-8% in all upper limb AVFs.
An alternative technique that may reduce risk of steal in this group of patients is to anastomose the vein to the radial artery or ulnar artery, distal to the brachial artery bifurcation. This technique, theoretically, will only 'steal' blood from one artery e.g. radial artery if the anastomosis is created on the proximal radial artery so blood flow can therefore be maintained by the ulnar arterial system.
Recent studies have suggested that using the proximal radial or ulnar artery reduced the risk of steal to as low as 0% to 3%. The type of arterial inflow to an AFF is therefore a potentially significant factor in causing steal syndrome. There is, however, no current randomised controlled trial to prove this hypothesis.
The definition of steal syndrome varies greatly in the literature. Some studies have defined steal syndrome as the presence of mild symptoms such as cold hand, while the others reported steal syndrome when it was severe enough to require surgical intervention. This has led to the huge variations in the incidence of steal syndrome being reported and has made comparison difficult between studies. A few scoring systems to describe the severity of steal syndrome have been suggested in previous studies, but none of them has been widely used.
In this study, the difference in the severity of steal between the two intervention groups will be investigated. This will be done using the Hoek score, which was originally used by Hoek et al in 2006 to report steal syndrome associated with the AVFs created in their centre. There was, however, no comparison of scores among the different types of AVF.
- Being tested
- Proximal radial/ulnar artery as inflow
- Medical subject headings
- Arteriovenous Fistula, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal radial/ulnar artery as inflowProcedure or surgery
Proximal radial/ulnar artery used as inflow
| Study group | Role | What they receive |
|---|---|---|
| Brachial artery inflow | No intervention | Elbow fistula created with brachial artery as inflow (ie. either brachiocephalic or brachiobasilic fistulas) |
| Proximal radial/ulnar artery as inflow | Active comparator | Elbow fistula created with either proximal radial or ulnar artery as inflow Receives: Procedure: Proximal radial/ulnar artery as inflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of steal syndrome as measured by Hoek Score
Determine the incidence of steal syndrome in the 2 arms of the study
Measured: 6 months
Secondary outcomes (3)
Presence of severe steal syndrome necessitating surgical revision/ligation
Determine the presence of severe steal syndrome necessitating surgical revision/ligation
Measured: 6 months
Operative time
Determine the efficacy of the two study interventions in terms of operative time.
Measured: 6 months
Utilisation of fistula
Determine the efficacy of the two study interventions in terms of utilisation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startFeb 2011
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulasStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Goh, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Gavin Pettigrew, MD, FRCS, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297451
- Sponsor's protocol ID
- A091982
- Other IDs
- 10/H0308/90
- Acronym
- STEAL
- Status last verified
- Jan 2020
- First submitted
- 29 Oct 2014
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing the Incidence of Steal Syndrome in the Two Types of anTEcubitaL Fossa Arteriovenous fistuLa AVF (STEAL Trial)
- ClinicalTrials.gov ID
- NCT02297451
- Acronym / sponsor ID
- STEAL / A091982
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 21 Nov 2014 (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.
Background:
Arteriovenous fistula (AVF) is a form of vascular access for haemodialysis. An AVF is normally created at the level of the wrist, but occasionally it is created in the elbow when there is no suitable vessel in the forearm. The most common type of elbow (antecubital) fistula (AFF) is a brachiocephalic fistula, which carries significantly higher risk of steal syndrome (AVF-associated hand ischaemia) than wrist fistulas. More recently, AFF using proximal radial or ulnar artery as inflow has been described and shown to have a lower rate of Steal syndrome than brachiocephalic fistula. This study aims to investigate the incidence of steal syndrome between AFF using brachial artery and that using the proximal radial/ulnar artery as inflow.
Detailed description
Arteriovenous fistulas (AVF) are the safest form of vascular access for long-term haemodialysis in patients with end-stage renal failure. The strategy in creating an AVF in the upper limbs is to start at a distal site and if that fails, to attempt an AVF on a more proximal site i.e. from wrist, forearm to elbow. The most common type of AVF is the radiocephalic AVF at the wrist. A more proximal AVF is often created as a primary procedure when there is poor vasculature in the distal forearm or as a secondary procedure when a wrist fistula has failed. Traditionally, brachiocephalic fistulas (BCF), which involves anastomosing the cephalic vein to the brachial artery, have been the most common type of AVF created in the antecubital fossa at the elbow level. Other common types of antecubital fossa arteriovenous fistula (AFF) are the brachiobasilic (BBF) and brachio-median cubital AVF.
Steal syndrome relates to hand ischaemia associated with AVF creation, and is a major risk of AVF formation. The symptoms of steal syndrome ranges from cold extremities, numbness, hand claudication (pain after exercise), to rest pain and tissue loss. Steal syndrome can also be measured by Digital Brachial Pressure Index. Severe steal syndrome is debilitating, and limb-threatening, and requires surgical revision or ligation of the AVF. This leads to additional surgical risks and loss of dialysis vascular access.
Diabetes and the types of AVF have been found to be independent risk factors for developing steal syndrome following AVF creation1. The highest risk is seen in patients with a proximal AVF i.e. BCF/BBF; up to 50% of patients in some studies, compared to 5-8% in all upper limb AVFs.
An alternative technique that may reduce risk of steal in this group of patients is to anastomose the vein to the radial artery or ulnar artery, distal to the brachial artery bifurcation. This technique, theoretically, will only 'steal' blood from one artery e.g. radial artery if the anastomosis is created on the proximal radial artery so blood flow can therefore be maintained by the ulnar arterial system.
Recent studies have suggested that using the proximal radial or ulnar artery reduced the risk of steal to as low as 0% to 3%. The type of arterial inflow to an AFF is therefore a potentially significant factor in causing steal syndrome. There is, however, no current randomised controlled trial to prove this hypothesis.
The definition of steal syndrome varies greatly in the literature. Some studies have defined steal syndrome as the presence of mild symptoms such as cold hand, while the others reported steal syndrome when it was severe enough to require surgical intervention. This has led to the huge variations in the incidence of steal syndrome being reported and has made comparison difficult between studies. A few scoring systems to describe the severity of steal syndrome have been suggested in previous studies, but none of them has been widely used.
In this study, the difference in the severity of steal between the two intervention groups will be investigated. This will be done using the Hoek score, which was originally used by Hoek et al in 2006 to report steal syndrome associated with the AVFs created in their centre. There was, however, no comparison of scores among the different types of AVF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brachial artery inflow | No intervention | –Elbow fistula created with brachial artery as inflow (ie. either brachiocephalic or brachiobasilic fistulas) |
| Proximal radial/ulnar artery as inflow | Active comparator | Procedure: Proximal radial/ulnar artery as inflowElbow fistula created with either proximal radial or ulnar artery as inflow |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- End stage renal failure Requiring AVF at in the antecubital fossa for haemodialysis
Key exclusion criteria (1 listed)
- When the participant has not received the allocated intervention due to anatomical anomaly, technical issue or any other reason
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 |
|---|---|---|
| Proximal radial/ulnar artery as inflowProximal radial/ulnar artery used as inflow | Procedure or surgery | Proximal radial/ulnar artery as inflow |
Primary outcome
Incidence of steal syndrome as measured by Hoek Score
Time frame: 6 months
Determine the incidence of steal syndrome in the 2 arms of the study
3 secondary outcomes
Presence of severe steal syndrome necessitating surgical revision/ligation
Time frame: 6 months
Operative time
Time frame: 6 months
Utilisation of fistula
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
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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.
Gavin Pettigrew, MD, FRCS principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal radial/ulnar artery as inflow in people with Arteriovenous Fistulas and Renal Failure, End-Stage, run by Cambridge University Hospitals NHS Foundation Trust 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Jan 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of steal syndrome as measured by Hoek Score (time frame: 6 months). 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 9 Jan 2020.