Hemodialysis Access FailureNIVADNCT04502160
The Northern Ireland Haemodialysis Vascular Access Database
An observational study of Hemodialysis Access Failure and Arteriovenous Fistula, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 105 years
- Conditions the study is for
- Hemodialysis Access Failure, Arteriovenous Fistula
- What is being tested?
- Vascular Access Creation
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2020to 22 Oct 2024
- 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 16 to 105 years
- All sexes
- Child, Adult, Older adult
Study population: Individuals undergoing AVF creation between January 2009 and December 2020 in a single centre (Belfast City Hospital
Who may be able to join
- Individuals attending Nephrology undergoing AVFcreation between January 2009 and December 2019 in a single centre (Belfast City Hospital
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Belfast City Hospital
Belfast, Antrim, BT9 7AB
Agnes Masengu, agnes.masengu@belfasttrust.hscni.net
Jennifer Hanko, jennifer.hanko@belfasttrust.hscni.net
About this study
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.
Read the 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..
- Conditions
- Hemodialysis Access Failure, Arteriovenous Fistula
- Being tested
- Vascular Access Creation
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Access CreationProcedure or surgery
Also called arteriovenous fistula creation
arteriovenous fistula creation
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Arteriovenous Fistula Failure to Mature
Rates of Arteriovenous Fistula Failure to Mature
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start15 Jun 2020
- Primary completion22 Oct 2024 (estimated)
- Study completion22 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis Access FailureStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Hanko, Principal investigator, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502160
- Sponsor's protocol ID
- 19089JH-SS
- Acronym
- NIVAD
- Status last verified
- Apr 2022
- First submitted
- 4 Aug 2020
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Would require application to Belfast Health and Social Care Trust Research and Development office
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Northern Ireland Haemodialysis Vascular Access Database
- ClinicalTrials.gov ID
- NCT04502160
- Acronym / sponsor ID
- NIVAD / 19089JH-SS
- Conditions
- Hemodialysis Access Failure, Arteriovenous Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 22 Oct 2024 (estimated)
- Study completion
- 22 Oct 2024 (estimated)
- First posted
- 6 Aug 2020 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 105 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals undergoing AVF creation between January 2009 and December 2020 in a single centre (Belfast City Hospital
Key inclusion criteria (1 listed)
- Individuals attending Nephrology undergoing AVFcreation between January 2009 and December 2019 in a single centre (Belfast City Hospital
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular Access CreationAlso: arteriovenous fistula creationarteriovenous fistula creation | Procedure or surgery | – |
Primary outcome
Rates of Arteriovenous Fistula Failure to Mature
Time frame: 1 year
Rates of Arteriovenous Fistula Failure to Mature
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No. Would require application to Belfast Health and Social Care Trust Research and Development office
Related trials for Hemodialysis Access Failure
Recruiting
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
End Stage Renal Disease (ESRD), Kidney Failure
Recruiting
The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion
Venous Stenosis, Venous Occlusion
Recruiting
Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
End Stage Renal Disease
Not yet recruiting
DialysisBot: AI Chatbot for Hemodialysis Self-Management
Chatbot-Based Training, Hemodialysis
Not yet recruiting
PATH-03 Paraguay Feasibility Study
Kidney Disease, End-Stage
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.
Jennifer Hanko principal investigator
Belfast Health and Social Care Trust
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 Hemodialysis Access Failure and Arteriovenous Fistula, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Apr 2022. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnes Masengu (0289043819, agnes.masengu@belfasttrust.hscni.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Arteriovenous Fistula Failure to Mature (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2022.