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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05801549
Other study ID # DVS007
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 13, 2022
Est. completion date January 10, 2023

Study information

Verified date April 2023
Source University Hospital of Limerick
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date January 10, 2023
Est. primary completion date December 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Ireland University Hospital Limerick Limerick

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Limerick

Country where clinical trial is conducted

Ireland, 

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Number of AVF's created We will determine how many were created surgically during the time frame. 3 years
Secondary AVF's in use for the purpose of Haemodialysis We will dtermine how many are in use for haemodialysis as planned. 3 years
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