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

Sponsor

The University of Queensland (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03969225

Collaborator

Australasian Kidney Trials Network (Other)

702

Enrollment

Locations

32.9

Anticipated Duration (Months)

70.2

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Access Complication Hemodialysis Access Failure (Disorder)

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

Study Type:

Observational

Actual Enrollment :

702 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 6, 2019

Actual Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

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. [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

Secondary Outcome Measures

Rate of vascular access interventions to enable and maintain the use of a vascular access for haemodialysis (number/patient-year). [6 months]
Interventions collected as listed in the Primary Outcome description
Time to first vascular access intervention to enable and maintain the use of a vascular access for haemodialysis (days). [6 months]
Interventions collected as listed in the Primary Outcome description
Type of vascular access interventions. [6 months]
Interventions collected as listed in the Primary Outcome description

Other Outcome Measures

Time required for measuring vascular access function (minutes) [6 months]
Feasibility outcome measures
Completeness of data collection (percentage) [6 months]
Feasibility outcome measures
Likert score of feasibility questionnaire with data collectors (scale of 1 to 5, 1=strongly disagree, 5=strongly agree) [6 months]
Feasibility outcome measures
Qualitative analysis of semi structured interview with data collector [6 months]
Feasibility outcome measures
Recruitment rate (number of participants/year) [6 months]
Feasibility outcome measures
Eligibility ratio (number of patients eligible/number of patients screened) [6 months]
Feasibility outcome measures
Enrolment ratio (number of patients enrolled/number of patients screened) [6 months]
Feasibility outcome measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Alexandra Hospital	Brisbane	Queensland	Australia	4110
2	Mackay Hospital	Mackay	Queensland	Australia	4740
3	Mater Hospital	Brisbane		Australia
4	Hervey Bay Hospital	Hervey Bay		Australia
5	University Health Network	Toronto		Canada
6	Centre Hospitalier Régional Universitaire de Tours	Tours		France
7	Hospital Sultanah Aminah Johor Bahru	Johor Bahru		Malaysia
8	Maastricht University Medical Centre	Maastricht		Netherlands
9	Ospedale Regionale di Lugano	Lugano		Switzerland
10	Sheffield Teaching Hospital	Sheffield		United Kingdom