- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05801549
Arterio-Venous Fistula Audit. Successful Utilisation Rates of Arterio-Venous Fistulae for Haemodialysis at University Hospital Limerick
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Limerick, Ireland
- University Hospital Limerick
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients outside of these set dates will be excluded.
- Patients who are not currently undergoing haemodialysis treatments are excluded.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of AVF's created
Time Frame: 3 years
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We will determine how many were created surgically during the time frame.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AVF's in use for the purpose of Haemodialysis
Time Frame: 3 years
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We will dtermine how many are in use for haemodialysis as planned.
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3 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DVS007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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