End Stage Renal FailureNCT01004627
A Study of Routine Versus Selective Use of Ultrasound Scanning Prior to Haemodialysis Fistula Surgery
A study testing Arterial and venous duplex ultrasound examination in people with End Stage Renal Failure and Surgery, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Dialysis patients have their blood filtered by a machine as their kidneys no longer work. To get blood in and out of these patients it is possible to perform a surgical procedure to increase to size and durability of a vein in the arm to allow repeated needle insertion. This enlarged vein is called a fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure, Surgery
- What is being tested?
- Arterial and venous duplex ultrasound examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Jan 2012
- 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
- Specific inclusion criteria necessary for invitation to study participation; Patients referred to vascular consultants for primary AV fistula formation (or primary fistula in that limb) for haemodialysis access.
- General inclusion criteria;
- Ability to give informed written consent
Who cannot join
- Specific exclusion criteria;
- Previous arterial or venous surgery/intervention performed on target limb.
- Known thrombophilic or thrombotic pathology.
- Aged under 18 at time of referral
- General exclusion criteria;
- Inability to give informed written consent
- Inability to attend follow up appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial of the Clinical Effectiveness of Obligatory Versus Elective Duplex Ultrasound Scanning Prior to Arteriovenous Fistula Formation for Haemodialysis Vascular Access in a University Teaching Hospital.
Dialysis patients have their blood filtered by a machine as their kidneys no longer work. To get blood in and out of these patients it is possible to perform a surgical procedure to increase to size and durability of a vein in the arm to allow repeated needle insertion. This enlarged vein is called a fistula. There is some evidence that ultrasound scanning the blood vessels in the arm before surgery can improve the chances of a successful procedure. The investigators aim to test whether scanning all patients is better than scanning only those who are difficult to assess by physical examination alone.
Read the detailed description
We will recruit all patients undergoing primary vascular access procedures in our unit who meet inclusion criteria. They will be randomised to either surgery based on clinical findings with duplex ultrasound only if requested by surgeon, or routine duplex ultrasound prior to surgery.
- Conditions
- End Stage Renal Failure, Surgery
- Being tested
- Arterial and venous duplex ultrasound examination
- Keywords
- fistula, ultrasound, angioaccess, preoperative vein mapping, Haemodialysis, Angioaccess surgery
- Medical subject headings
- Renal Insufficiency, Chronic, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial and venous duplex ultrasound examinationProcedure or surgery
Ultrasound mapping of all blood vessels in the upper limb of interest
| Study group | Role | What they receive |
|---|---|---|
| Control group - selective duplex | No intervention | Patients will receive a duplex ultrasound only if specifically requested following physical examination. |
| Obligatory Duplex scan | Experimental | Patients will receive a duplex ultrasound regardless of clinical findings. Arterial and venous duplex ultrasound examination Receives: Procedure: Arterial and venous duplex ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary failure of access (immediate/early thrombosis or failure to mature).
Measured: 30 days
Secondary outcomes (5)
Assisted primary patency - being the interval from placement until the time of measurement of patency, including intervening manipulations
Measured: open ended
Secondary patency - The interval from placement until time of patency measurement including intervening manipulations
Measured: open ended
Site of fistula created
Measured: within 1 month of recruitment
Functional primary patency - being the interval from the time of access placement until any intervention designed to maintain or re-establish patency or the time of measurement of patency during which the AVF provides dialysis access.
Measured: open ended
Surgeon grade
Measured: open ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startMar 2010
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
- Investigators
- Ian C Chetter, MBChB FRCS MD, Principal investigator, Hull University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004627
- Sponsor's protocol ID
- Access 1
- Status last verified
- Jul 2019
- First submitted
- 29 Oct 2009
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith GE, Barnes R, Chetter IC. Randomized clinical trial of selective versus routine preoperative duplex ultrasound imaging before arteriovenous fistula surgery. Br J Surg. 2014 Apr;101(5):469-74. doi: 10.1002/bjs.9435. Epub 2014 Feb 20.
PubMed 24756913
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of the Clinical Effectiveness of Obligatory Versus Elective Duplex Ultrasound Scanning Prior to Arteriovenous Fistula Formation for Haemodialysis Vascular Access in a University Teaching Hospital.
- ClinicalTrials.gov ID
- NCT01004627
- Acronym / sponsor ID
- Access 1
- Conditions
- End Stage Renal Failure, Surgery
- Keywords
- fistula, ultrasound, angioaccess, preoperative vein mapping, Haemodialysis, Angioaccess surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- Mar 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 30 Oct 2009 (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.
Dialysis patients have their blood filtered by a machine as their kidneys no longer work. To get blood in and out of these patients it is possible to perform a surgical procedure to increase to size and durability of a vein in the arm to allow repeated needle insertion. This enlarged vein is called a fistula. There is some evidence that ultrasound scanning the blood vessels in the arm before surgery can improve the chances of a successful procedure. The investigators aim to test whether scanning all patients is better than scanning only those who are difficult to assess by physical examination alone.
Detailed description
We will recruit all patients undergoing primary vascular access procedures in our unit who meet inclusion criteria. They will be randomised to either surgery based on clinical findings with duplex ultrasound only if requested by surgeon, or routine duplex ultrasound prior to surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group - selective duplex | No intervention | –Patients will receive a duplex ultrasound only if specifically requested following physical examination. |
| Obligatory Duplex scan | Experimental | Procedure: Arterial and venous duplex ultrasound examinationPatients will receive a duplex ultrasound regardless of clinical findings. Arterial and venous duplex ultrasound examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Specific inclusion criteria necessary for invitation to study participation; Patients referred to vascular consultants for primary AV fistula formation (or primary fistula in that limb) for haemodialysis access.
- General inclusion criteria;
- Ability to give informed written consent
Key exclusion criteria (7 listed)
- Specific exclusion criteria;
- General exclusion criteria;
- Inability to give informed written consent
- Inability to attend follow up appointments
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 |
|---|---|---|
| Arterial and venous duplex ultrasound examinationUltrasound mapping of all blood vessels in the upper limb of interest | Procedure or surgery | Obligatory Duplex scan |
Primary outcome
Primary failure of access (immediate/early thrombosis or failure to mature).
Time frame: 30 days
5 secondary outcomes
Assisted primary patency - being the interval from placement until the time of measurement of patency, including intervening manipulations
Time frame: open ended
Secondary patency - The interval from placement until time of patency measurement including intervening manipulations
Time frame: open ended
Site of fistula created
Time frame: within 1 month of recruitment
Functional primary patency - being the interval from the time of access placement until any intervention designed to maintain or re-establish patency or the time of measurement of patency during which the AVF provides dialysis access.
Time frame: open ended
Surgeon grade
Time frame: open ended
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 12 Jul 2019.
- Results publication: PubMed 24756913Smith GE, Barnes R, Chetter IC. Randomized clinical trial of selective versus routine preoperative duplex ultrasound imaging before arteriovenous fistula surgery. Br J Surg. 2014 Apr;101(5):469-74. doi: 10.1002/bjs.9435. Epub 2014 Feb 20.
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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.
Ian C Chetter, MBChB FRCS MD principal investigator
Hull University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial and venous duplex ultrasound examination in people with End Stage Renal Failure and Surgery, run by Hull University Teaching Hospitals NHS 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 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: finished, as of the sponsor's last update on 12 Jul 2019. 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?
Primary failure of access (immediate/early thrombosis or failure to mature). (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01004627, which also lists 1 linked publication.
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 12 Jul 2019.