Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis (VALID)
Secondary ID [1] 0 0
AKTN 19.01
Universal Trial Number (UTN)
Trial acronym
VALID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular Access Complication 0 0
Hemodialysis Access Failure (Disorder) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Rate of vascular access interventions to enable and maintain the use of a vascular access for haemodialysis (number/patient-year).
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Time to first vascular access intervention to enable and maintain the use of a vascular access for haemodialysis (days).
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Type of vascular access interventions.
Timepoint [3] 0 0
6 months

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/02/2023
Sample size
Target
Accrual to date
Final
702
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Mackay Hospital - Mackay
Recruitment hospital [3] 0 0
Mater Hospital - Brisbane
Recruitment hospital [4] 0 0
Hervey Bay Hospital - Hervey Bay
Recruitment postcode(s) [1] 0 0
4110 - Brisbane
Recruitment postcode(s) [2] 0 0
4740 - Mackay
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Hervey Bay
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Toronto
Country [2] 0 0
France
State/province [2] 0 0
Tours
Country [3] 0 0
Malaysia
State/province [3] 0 0
Johor Bahru
Country [4] 0 0
Netherlands
State/province [4] 0 0
Maastricht
Country [5] 0 0
Switzerland
State/province [5] 0 0
Lugano
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Kidney Trials Network
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03969225
Trial related presentations / publications
Viecelli AK, Teixeira-Pinto A, Valks A, Baer R, Cherian R, Cippa PE, Craig JC, DeSilva R, Jaure A, Johnson DW, Kiriwandeniya C, Kopperschmidt P, Liu WJ, Lee T, Lok C, Madhan K, Mallard AR, Oliver V, Polkinghorne KR, Quinn RR, Reidlinger D, Roberts M, Sautenet B, Hooi LS, Smith R, Snoeijs M, Tordoir J, Vachharajani TJ, Vanholder R, Vergara LA, Wilkie M, Yang B, Yuo TH, Zou L, Hawley CM; VALID Investigator Team. Study protocol for Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) : A multi-center, multinational validation study to assess the accuracy and feasibility of measuring vascular access function in clinical practice. BMC Nephrol. 2022 Nov 19;23(1):372. doi: 10.1186/s12882-022-02987-1.
Public notes

Contacts
Principal investigator
Name 0 0
Andrea Viecelli, MD, FRAC
Address 0 0
Princess Alexandra Hospital and Australasian Kidney Trials Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03969225