The Northern Ireland Haemodialysis Vascular Access Database (NIVAD)

April 14, 2022 updated by: Belfast Health and Social Care Trust
This is database designed to explore clinical outcomes related to vascular assess in the population of Northern Ireland with CKD Stage 5 and End-stage Renal Failure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Vascular access is the conduit by which blood is transferred from the patient to the dialysis machine and back to the patient during therapy. There are three types of vascular access: Arteriovenous fistulas (AVF), Central venous catheters (CVC) and Arteriovenous grafts (AVG).

AVFs are associated with the best patient survival in individuals undergoing dialysis therapy. However, Up 30-50% of AVFs thrombose or fail to mature sufficiently to support dialysis.

The aim of this database is to further research in the area of AVF outcomes using routinely collected clinical data..

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 105 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals undergoing AVF creation between January 2009 and December 2020 in a single centre (Belfast City Hospital

Description

Inclusion Criteria:

  • Individuals attending Nephrology undergoing AVFcreation between January 2009 and December 2019 in a single centre (Belfast City Hospital

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Arteriovenous Fistula Failure to Mature
Time Frame: 1 year
Rates of Arteriovenous Fistula Failure to Mature
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belfast Health and Social Care Trust

Investigators

  • Principal Investigator: Jennifer Hanko, Belfast Health and Social Care Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2020

Primary Completion (ANTICIPATED)

October 22, 2024

Study Completion (ANTICIPATED)

October 22, 2024

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (ACTUAL)

August 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19089JH-SS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Would require application to Belfast Health and Social Care Trust Research and Development office

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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