Arterio-venous FistulaNCT05801549
Arterio-Venous Fistula Audit. Successful Utilisation Rates of Arterio-Venous Fistulae for Haemodialysis at University Hospital Limerick
An observational study of Arterio-venous Fistula, run by University Hospital of Limerick at 1 site in Ireland.
Trial summary
We wish to examine Arterio-Venous Fistula (AVF) and Arterio-Venous Graft (AVG) utilisation rates for Haemodialysis at University Hospital Limerick. We want to determine out of the AVF's that are surgically created, how many go on to be used as anticipated for haemodialysis treatments successfully. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterio-venous Fistula
- How many people
- 70 participants
- Where
- 1 siteIreland
- Study dates
- 13 Sep 2022to 10 Jan 2023
- Phase
- Observational
- 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
Study population: All patients who had an AVF or AVG surgically created over the last three years at UHL who are undergoing haemodialysis treatments are suitable for inclusion. Dates for audit purposes are 1st April 2019 to 1st April 2022.
Who may be able to join
- Patients who had an AVF or AVG surgically created over the last three years at UHL who are undergoing haemodialysis treatments are suitable for inclusion.
- Dates for audit purposes are 1st April 2019 to 1st April 2022.
Who cannot join
- Patients outside of these set dates will be excluded.
- Patients who are not currently undergoing haemodialysis treatments are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
We wish to examine Arterio-Venous Fistula (AVF) and Arterio-Venous Graft (AVG) utilisation rates for Haemodialysis at University Hospital Limerick. We want to determine out of the AVF's that are surgically created, how many go on to be used as anticipated for haemodialysis treatments successfully.
Read the detailed description
There are over 2 million end-stage renal disease (ESRD) patients who require renal replacement therapy worldwide, and this is estimated to rise to over 5 million by 2030 (Liyanage et al. 2015).
Haemodialysis, used by the majority of ESRD patients, requires vascular access, where blood can be taken out of the body (via cannulation) and pumped through an external dialysis machine, which filters the blood of waste and excess fluid before being returned.
Arterio-venous fistula creation is the preferred vascular access for haemodialysis, but has a large failure rate in the maturation period (Colley et al. 2022). Failure is usually attributed to insufficient dilation of the vessel and/or stenosis, which results in inadequate blood flow rates for the purpose of haemodialysis (Dixon, 2006).
The purpose of this audit is to examine over a three year period how many of the individuals who had an AVF created are utilising it successfully for the purpose of haemodialysis as planned.
- Conditions
- Arterio-venous Fistula
- Medical subject headings
- Arteriovenous Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of AVF's created
We will determine how many were created surgically during the time frame.
Measured: 3 years
Secondary outcomes (1)
AVF's in use for the purpose of Haemodialysis
We will dtermine how many are in use for haemodialysis as planned.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start13 Sep 2022
- Primary completion9 Dec 2022
- Study completion10 Jan 2023
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 Arterio-venous FistulaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona Leahy, University Hospital of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801549
- Sponsor's protocol ID
- DVS007
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Colley, E., Carroll, J., Anne, S., Shannon, T., Ramon, V. and Tracie, B. (2022). A longitudinal study of the arterio-venous fistula maturation of a single patient over 15 weeks. Biomechanics and Modeling in Mechanobiology, pp.1-16. Dixon, B.S. (2006). Why don't fistulas mature? Kidney International, 70 (8): pp1413-1422. Liyanage, T., Ninomiya, T., Jha, V., Neal, B., Patrice, H.M., Okpechi, I., Zhao, M.H., Lv, J., Garg, A.X., Knight, J. and Rodgers, A. (2015). Worldwide access to treatment for end-stage kidney disease: a systematic review. The Lancet, 385 (9981), pp.1975-1982.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterio-Venous Fistula Audit. Successful Utilisation Rates of Arterio-Venous Fistulae for Haemodialysis at University Hospital Limerick
- ClinicalTrials.gov ID
- NCT05801549
- Acronym / sponsor ID
- DVS007
- Conditions
- Arterio-venous Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital of LimerickUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 6 Apr 2023 (actual)
- 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.
We wish to examine Arterio-Venous Fistula (AVF) and Arterio-Venous Graft (AVG) utilisation rates for Haemodialysis at University Hospital Limerick. We want to determine out of the AVF's that are surgically created, how many go on to be used as anticipated for haemodialysis treatments successfully.
Detailed description
There are over 2 million end-stage renal disease (ESRD) patients who require renal replacement therapy worldwide, and this is estimated to rise to over 5 million by 2030 (Liyanage et al. 2015).
Haemodialysis, used by the majority of ESRD patients, requires vascular access, where blood can be taken out of the body (via cannulation) and pumped through an external dialysis machine, which filters the blood of waste and excess fluid before being returned.
Arterio-venous fistula creation is the preferred vascular access for haemodialysis, but has a large failure rate in the maturation period (Colley et al. 2022). Failure is usually attributed to insufficient dilation of the vessel and/or stenosis, which results in inadequate blood flow rates for the purpose of haemodialysis (Dixon, 2006).
The purpose of this audit is to examine over a three year period how many of the individuals who had an AVF created are utilising it successfully for the purpose of haemodialysis as planned.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had an AVF or AVG surgically created over the last three years at UHL who are undergoing haemodialysis treatments are suitable for inclusion. Dates for audit purposes are 1st April 2019 to 1st April 2022.
Key inclusion criteria (2 listed)
- Patients who had an AVF or AVG surgically created over the last three years at UHL who are undergoing haemodialysis treatments are suitable for inclusion.
- Dates for audit purposes are 1st April 2019 to 1st April 2022.
Key exclusion criteria (2 listed)
- Patients outside of these set dates will be excluded.
- Patients who are not currently undergoing haemodialysis treatments are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of AVF's created
Time frame: 3 years
We will determine how many were created surgically during the time frame.
1 secondary outcome
AVF's in use for the purpose of Haemodialysis
Time frame: 3 years
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 6 Apr 2023.
- BackgroundColley, E., Carroll, J., Anne, S., Shannon, T., Ramon, V. and Tracie, B. (2022). A longitudinal study of the arterio-venous fistula maturation of a single patient over 15 weeks. Biomechanics and Modeling in Mechanobiology, pp.1-16. Dixon, B.S. (2006). Why don't fistulas mature? Kidney International, 70 (8): pp1413-1422. Liyanage, T., Ninomiya, T., Jha, V., Neal, B., Patrice, H.M., Okpechi, I., Zhao, M.H., Lv, J., Garg, A.X., Knight, J. and Rodgers, A. (2015). Worldwide access to treatment for end-stage kidney disease: a systematic review. The Lancet, 385 (9981), pp.1975-1982.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Arterio-venous Fistula, run by University Hospital of Limerick at 1 site in Ireland.
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 2 inclusion and 2 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 6 Apr 2023. 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 Ireland. 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?
Number of AVF's created (time frame: 3 years). 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 NCT05801549, 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 6 Apr 2023.