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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03969225
Registration number
NCT03969225
Ethics application status
Date submitted
10/05/2019
Date registered
31/05/2019
Date last updated
10/05/2024
Titles & IDs
Public title
Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis
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Scientific title
Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis (VALID)
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Secondary ID [1]
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AKTN 19.01
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Universal Trial Number (UTN)
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Trial acronym
VALID
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vascular Access Complication
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Hemodialysis Access Failure (Disorder)
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Reporting of vascular access function, defined by the need for any intervention(s) required to enable and maintain the use of a vascular access for haemodialysis. Vascular access interventions to be collected are outlined in the description below.
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Assessment method [1]
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Arteriovenous fistula (AVF)/Arteriovenous graft (AVG)
Open surgical or endovascular creation/placement of AVF/AVG
Open surgical revision or endovascular intervention of AVG/AVF
Thrombolysis or thrombectomy of AVG/AVF
Ligation or resection of arteriovenous access
Repair of aneurysm/pseudoaneurysm
Competing/collateral vein ligation
Fistulogram (Angiogram) +/- angioplasty +/- stenting (including inflow artery, body of AVF/AVG, venous outflow, central vein)
Competing/collateral vein embolisation
Superficialisation/transposition
Management of Dialysis Associated Steal Syndrome (DASS)/Access Induced Ischaemia. Procedures include:
Distal Revascularisation, Interval Ligation (DRIL)
Proximalisation of the Arterial Inflow (PAI)
Revision Using Distal Inflow (RUDI)
Banding
Central venous catheter (CVC)
CVC insertion
CVC exchange
Fibrin sheath removal/disruption
CVC removal
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Rate of vascular access interventions to enable and maintain the use of a vascular access for haemodialysis (number/patient-year).
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Assessment method [1]
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Interventions collected as listed in the Primary Outcome description
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Time to first vascular access intervention to enable and maintain the use of a vascular access for haemodialysis (days).
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Assessment method [2]
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Interventions collected as listed in the Primary Outcome description
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Type of vascular access interventions.
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Assessment method [3]
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Interventions collected as listed in the Primary Outcome description
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Timepoint [3]
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6 months
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Eligibility
Key inclusion criteria
- Patients new to or established on chronic haemodialysis (i.e. incident and prevalent
patients on chronic haemodialysis)
- Patients 18 years or more of age
- Able to provide informed consent (if consent is required).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Anticipated to require haemodialysis for less than 90 days
- Treating team considers patient unsuitable to be enrolled
- Patient or authorised representative not willing to consent (if consent is required).
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/12/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/02/2023
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Sample size
Target
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Accrual to date
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Final
702
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [2]
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Mackay Hospital - Mackay
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Recruitment hospital [3]
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Mater Hospital - Brisbane
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Recruitment hospital [4]
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Hervey Bay Hospital - Hervey Bay
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Recruitment postcode(s) [1]
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4110 - Brisbane
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Recruitment postcode(s) [2]
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4740 - Mackay
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Recruitment postcode(s) [3]
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- Brisbane
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Recruitment postcode(s) [4]
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- Hervey Bay
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Toronto
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Country [2]
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France
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State/province [2]
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Tours
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Country [3]
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Malaysia
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State/province [3]
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Johor Bahru
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Country [4]
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Netherlands
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State/province [4]
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Maastricht
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Country [5]
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Switzerland
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State/province [5]
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Lugano
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Country [6]
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United Kingdom
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State/province [6]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australasian Kidney Trials Network
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
A functioning vascular access provides a lifeline for patients requiring haemodialysis but
vascular access dysfunction remains one of the leading causes of excessive morbidity,
mortality and healthcare costs in this group. Despite increasing numbers of vascular access
trials, successful interventions to improve vascular access function have been sparse and
compromised by highly variable, often selectively reported outcome measures of limited
relevance to patients and health professionals. Through engagement of all relevant
stakeholders including patients and caregivers, vascular access function, defined by the need
for interventions to enable and maintain the use of a vascular access for haemodialysis, has
been identified as one of the most critically important outcome measures for trials in
haemodialysis. This prospective, multi-centre, multinational validation study aims to assess
the accuracy and feasibility of measuring vascular access function part of routine clinical
practice and across different clinical settings to ensure successful global implementation of
this core outcome measure in future trials in haemodialysis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03969225
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Andrea Viecelli, MD, FRAC
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Address
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Princess Alexandra Hospital and Australasian Kidney Trials Network
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03969225
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