Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis

NCT03969225 | Completed

• 1 other identifier: AKTN 19.01
• Study Type: observational
• Target: 702
• Locations: 7 countries
• Sites: 10

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.

Conditions

Vascular Access Complication; Hemodialysis Access Failure (Disorder)

Keywords

Haemodialysis vascular access; Core outcome; Vascular access function; Validation; Haemodialysis; Hemodialysis; Vascular access intervention; Vascular access procedure; Standardised outcomes in nephrology (SONG)

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  6 months

• Time to first vascular access intervention to enable and maintain the use of a vascular access for haemodialysis (days).

  6 months

• Type of vascular access interventions.

  6 months

Other Outcomes (7)

• Time required for measuring vascular access function (minutes)

  6 months

• Completeness of data collection (percentage)

  6 months

• Likert score of feasibility questionnaire with data collectors (scale of 1 to 5, 1=strongly disagree, 5=strongly agree)

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Queensland: lead
• Australasian Kidney Trials Network: collaborator

Study Sites (10)

Princess Alexandra Hospital

Brisbane, Queensland, 4110, Australia

Location

Mackay Hospital

Mackay, Queensland, 4740, Australia

Location

Mater Hospital

Brisbane, Australia

Location

Hervey Bay Hospital

Hervey Bay, Australia

Location

University Health Network

Toronto, Canada

Location

Centre Hospitalier Régional Universitaire de Tours

Tours, France

Location

Hospital Sultanah Aminah Johor Bahru

Johor Bahru, Malaysia

Location

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Ospedale Regionale di Lugano

Lugano, Switzerland

Location

Sheffield Teaching Hospital

Sheffield, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36402958 DERIVED

Related Links

• Enhancing the Quality and Transparency of health research (EQUATOR network). STARD 2015: An updated List of Essential Items for Reporting Diagnostic Accuracy Studies.
• Standardised Outcomes in Nephrology (SONG) initiative. SONG-Haemodialysis Vascular Access Expert Working Group
• Standardised Outcomes in Nephrology (SONG) Initiative. SONG Handbook (Version 1, 1st June 2017) for establishing and implementing core outcomes in chronic kidney disease.

Study Officials

• Andrea Viecelli, MD, FRAC

  Princess Alexandra Hospital and Australasian Kidney Trials Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 31, 2019
• Study Start: December 6, 2019
• Primary Completion: October 30, 2022
• Study Completion: February 17, 2023
• Last Updated: May 10, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: This process will be in effect for a period of 2 to 5 years following publication of the main study results. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in the Sponsor's data warehouse but without investigator support other than deposited metadata.
• Access Criteria: An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.

Locations

GB (1); AU (4); FR (1); NL (1); CH (1); MY (1); CA (1)