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NCT04502160 Clinical Trial

The Northern Ireland Haemodialysis Vascular Access Database

Arteriovenous Fistula Clinical Trial

— NIVAD  

Official title:
The Northern Ireland Haemodialysis Vascular Access Database

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04502160
Other study ID # 19089JH-SS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 15, 2020
Est. completion date October 22, 2024

Study information
Verified date April 2022
Source Belfast Health and Social Care Trust
Contact Agnes Masengu
Phone 0289043819
Email agnes.masengu@belfasttrust.hscni.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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..

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date October 22, 2024
Est. primary completion date October 22, 2024
Accepts healthy volunteers
Gender All
Age group 16 Years to 105 Years
Eligibility Inclusion Criteria: - Individuals attending Nephrology undergoing AVFcreation between January 2009 and December 2019 in a single centre (Belfast City Hospital Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Vascular Access Creation
arteriovenous fistula creation

Locations
Country Name City State
United Kingdom Belfast City Hospital Belfast Antrim

Sponsors (1)
Lead Sponsor Collaborator
Belfast Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rates of Arteriovenous Fistula Failure to Mature Rates of Arteriovenous Fistula Failure to Mature 1 year
See also
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Recruiting NCT04017806 - Investigating the Role of Luminal Pressure on Arteriovenous Fistula Maturation
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Completed NCT06199609 - Changes in Cardiac Structure and Function After Establishment of Autologous Arteriovenous Fistula
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Active, not recruiting NCT04629118 - Intervention With Selution SLR™ Agent Balloon for Endovascular Latent Limus Therapy for Failing AV Fistulas (ISABELLA) Trial
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Completed NCT02513303 - Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes Phase 3
Completed NCT01863914 - Vascular Protective Effect of Rosuvastatin in Arteriovenous Fistula Phase 2
Recruiting NCT06001827 - SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study N/A
Recruiting NCT04543539 - IN.PACT™ AV Access Post-Approval Study (PAS002)
Completed NCT05326321 - Effect of Virtual Reality Glasses in The Arteriovenous Fistule Cannulation Processon Paın and Patient Satisfaction N/A
Recruiting NCT03741985 - Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis N/A
Terminated NCT03566927 - FLEX®-DCB Dialysis ACCESS Stenosis Study N/A
Not yet recruiting NCT04393688 - Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula N/A
Recruiting NCT02447796 - Dexmedetomidine and Propofol As Sole Sedative Agent for Patients Undergoing Arteriovenous Fistula Surgery Phase 4
Terminated NCT01321866 - Cutting Balloon Versus Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients N/A