Vascular Access ComplicationVALIDNCT03969225
Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis
An observational study of Vascular Access Complication and Hemodialysis Access Failure (Disorder), run by The University of Queensland at 10 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Hemodialysis Access Failure (Disorder)
- How many people
- 702 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 6 Dec 2019to 17 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients receiving chronic haemodialysis in the participating unit and who are able and willing to provide informed consent, will be invited to take part in the trial. Patients who are expected to require haemodialysis for less than 3 months due to anticipated recovery of renal function will be excluded. The eligibility criteria are deliberately kept broad to reflect routine clinical practice (i.e. not excluding non-English speaking patients) and avoid selection bias within participating units. Paediatric patients are excluded because vascular access outcomes were not considered a core outcome domain for research in paediatric patients with chronic kidney disease as established by the SONG-Kids initiative involving children, adolescence, their family members, and health professionals.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
Australia4 sites
Princess Alexandra Hospital
Brisbane, Queensland, 4110
Mater Hospital
Brisbane
Hervey Bay Hospital
Hervey Bay
Mackay Hospital
Mackay, Queensland, 4740
About this study
Official title: Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis (VALID)
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.
Read the detailed description
Haemodialysis is the most common treatment for patients with end-stage kidney disease worldwide and can only be provided via a functional vascular access. Patients, caregivers and health professionals consider vascular access function one of the most critically important outcomes in haemodialysis but trial-based evidence to improve vascular access function is limited by the inconsistent and selective reporting of this outcome. Reporting of a standardised outcome measure for vascular access function across all trials in haemodialysis will enhance the consistency and relevance of trial evidence to guide patient-centred care. Based on international contribution of all relevant stakeholders including patients, the need of interventions to enable and maintain the use of a vascular access for haemodialysis was considered a simple, pragmatic, and meaningful measure of vascular access function. To ensure global implementation across all trial in haemodialysis, it needs to be feasible to accurately collect this outcome measure as part of routine clinical practice without requiring additional resources or expertise in vascular access.
VALID is a prospective, multi-centre, multinational validation study to assess the accuracy and feasibility of measuring vascular access function, defined by the need for interventions to enable and maintain the use of a vascular access for haemodialysis by clinical staff as part of their routing clinical practice and across different clinical settings.
The primary objective of the VALID study is to determine whether vascular access function can be measured accurately by clinical staff as part of routine clinical practice compared to the reference standard of a research team with expertise in vascular access during a 6-month follow-up period.
An estimated 612 participants will be recruited from approximately 10 dialysis units of difference size, type (home-, in-centre and satellite), governance (private versus public), and location (rural versus urban) across Australia, Canada, China, France, United Kingdom, Netherlands, Malaysia and the United States of America (USA).
Implementation of a validated outcome measure for vascular access function across clinical trials will improve the reliability, comparability and relevance of future research in haemodialysis to inform patient-centred care.
- Keywords
- Haemodialysis vascular access, Core outcome, Vascular access function, Validation, Haemodialysis, Hemodialysis, Vascular access intervention, Vascular access procedure, Standardised outcomes in nephrology (SONG)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
Measured: 6 months
Secondary outcomes (3)
Rate of vascular access interventions to enable and maintain the use of a vascular access for haemodialysis (number/patient-year).
Interventions collected as listed in the Primary Outcome description
Measured: 6 months
Time to first vascular access intervention to enable and maintain the use of a vascular access for haemodialysis (days).
Interventions collected as listed in the Primary Outcome description
Measured: 6 months
Type of vascular access interventions.
Interventions collected as listed in the Primary Outcome description
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start6 Dec 2019
- Primary completion30 Oct 2022
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Access ComplicationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Australasian Kidney Trials Network
- Responsible party
- Sponsor
- Investigators
- Andrea Viecelli, MD, FRAC, Principal investigator, Princess Alexandra Hospital and Australasian Kidney Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969225
- Sponsor's protocol ID
- AKTN 19.01
- Acronym
- VALID
- Status last verified
- Aug 2022
- First submitted
- 10 May 2019
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.
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.
PubMed 36402958
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis (VALID)
- ClinicalTrials.gov ID
- NCT03969225
- Acronym / sponsor ID
- VALID / AKTN 19.01
- Keywords
- Haemodialysis vascular access, Core outcome, Vascular access function, Validation, Haemodialysis, Hemodialysis, Vascular access intervention, Vascular access procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 702 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Australasian Kidney Trials Network
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 31 May 2019 (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.
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.
Detailed description
Haemodialysis is the most common treatment for patients with end-stage kidney disease worldwide and can only be provided via a functional vascular access. Patients, caregivers and health professionals consider vascular access function one of the most critically important outcomes in haemodialysis but trial-based evidence to improve vascular access function is limited by the inconsistent and selective reporting of this outcome. Reporting of a standardised outcome measure for vascular access function across all trials in haemodialysis will enhance the consistency and relevance of trial evidence to guide patient-centred care. Based on international contribution of all relevant stakeholders including patients, the need of interventions to enable and maintain the use of a vascular access for haemodialysis was considered a simple, pragmatic, and meaningful measure of vascular access function. To ensure global implementation across all trial in haemodialysis, it needs to be feasible to accurately collect this outcome measure as part of routine clinical practice without requiring additional resources or expertise in vascular access.
VALID is a prospective, multi-centre, multinational validation study to assess the accuracy and feasibility of measuring vascular access function, defined by the need for interventions to enable and maintain the use of a vascular access for haemodialysis by clinical staff as part of their routing clinical practice and across different clinical settings.
The primary objective of the VALID study is to determine whether vascular access function can be measured accurately by clinical staff as part of routine clinical practice compared to the reference standard of a research team with expertise in vascular access during a 6-month follow-up period.
An estimated 612 participants will be recruited from approximately 10 dialysis units of difference size, type (home-, in-centre and satellite), governance (private versus public), and location (rural versus urban) across Australia, Canada, China, France, United Kingdom, Netherlands, Malaysia and the United States of America (USA).
Implementation of a validated outcome measure for vascular access function across clinical trials will improve the reliability, comparability and relevance of future research in haemodialysis to inform patient-centred care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving chronic haemodialysis in the participating unit and who are able and willing to provide informed consent, will be invited to take part in the trial. Patients who are expected to require haemodialysis for less than 3 months due to anticipated recovery of renal function will be excluded. The eligibility criteria are deliberately kept broad to reflect routine clinical practice (i.e. not excluding non-English speaking patients) and avoid selection bias within participating units. Paediatric patients are excluded because vascular access outcomes were not considered a core outcome domain for research in paediatric patients with chronic kidney disease as established by the SONG-Kids initiative involving children, adolescence, their family members, and health professionals.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 6 months
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
3 secondary outcomes
Rate of vascular access interventions to enable and maintain the use of a vascular access for haemodialysis (number/patient-year).
Time frame: 6 months
Time to first vascular access intervention to enable and maintain the use of a vascular access for haemodialysis (days).
Time frame: 6 months
Type of vascular access interventions.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Derived from this study: PubMed 36402958Viecelli 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.
- Enhancing the Quality and Transparency of health research (EQUATOR network). STARD 2015: An updated List of Essential Items for Reporting Diagnostic Accuracy Studies.Link provided by the sponsor.
- Standardised Outcomes in Nephrology (SONG) initiative. SONG-Haemodialysis Vascular Access Expert Working GroupLink provided by the sponsor.
- Standardised Outcomes in Nephrology (SONG) Initiative. SONG Handbook (Version 1, 1st June 2017) for establishing and implementing core outcomes in chronic kidney disease.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.
Related trials for Vascular Access Complication
Not yet recruiting
Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
Vascular Access Devices, Vascular Access
RecruitingObservational study
Mobilisation After Endovascular Stroke Treatment
Stroke, Acute Ischemic Stroke
RecruitingPhase 2
The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas
Amyloidosis, Basal Cell Carcinoma
Recruiting
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Type 1 Diabetes, Type 2 Diabetes
Not yet recruiting
DialysisBot: AI Chatbot for Hemodialysis Self-Management
Chatbot-Based Training, Hemodialysis
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.
Andrea Viecelli, MD, FRAC principal investigator
Princess Alexandra Hospital and Australasian Kidney Trials Network
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Access Complication and Hemodialysis Access Failure (Disorder), run by The University of Queensland at 10 sites in 7 countries.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, Canada, France, Malaysia, Netherlands and 2 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03969225, which also lists 1 linked publication.
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 10 May 2024.