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

Vascular Access Complication Clinical Trial

— VALID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969225
• Other study ID #: AKTN 19.01
• Status: Completed
• Start date: December 6, 2019
• Est. completion date: February 17, 2023

Study information

• Verified date: August 2022
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 702
• Est. completion date: February 17, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hemodialysis Access Failure (Disorder)
• Vascular Access Complication

Locations

Country	Name	City	State
Australia	Mater Hospital	Brisbane
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Hervey Bay Hospital	Hervey Bay
Australia	Mackay Hospital	Mackay	Queensland
Canada	University Health Network	Toronto
France	Centre Hospitalier Régional Universitaire de Tours	Tours
Malaysia	Hospital Sultanah Aminah Johor Bahru	Johor Bahru
Netherlands	Maastricht University Medical Centre	Maastricht
Switzerland	Ospedale Regionale di Lugano	Lugano
United Kingdom	Sheffield Teaching Hospital	Sheffield

Sponsors (2)

Lead Sponsor	Collaborator
The University of Queensland	Australasian Kidney Trials Network

Countries where clinical trial is conducted

Australia,  Canada,  France,  Malaysia,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time required for measuring vascular access function (minutes)	Feasibility outcome measures	6 months
Other	Completeness of data collection (percentage)	Feasibility outcome measures	6 months
Other	Likert score of feasibility questionnaire with data collectors (scale of 1 to 5, 1=strongly disagree, 5=strongly agree)	Feasibility outcome measures	6 months
Other	Qualitative analysis of semi structured interview with data collector	Feasibility outcome measures	6 months
Other	Recruitment rate (number of participants/year)	Feasibility outcome measures	6 months
Other	Eligibility ratio (number of patients eligible/number of patients screened)	Feasibility outcome measures	6 months
Other	Enrolment ratio (number of patients enrolled/number of patients screened)	Feasibility outcome measures	6 months
Primary	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	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	6 months
Secondary	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	6 months
Secondary	Type of vascular access interventions.	Interventions collected as listed in the Primary Outcome description	6 months

External 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 Handbook (Version 1, 1st June 2017) for establishing and implementing core outcomes in chronic kidney disease.
•   Standardised Outcomes in Nephrology (SONG) initiative. SONG-Haemodialysis Vascular Access Expert Working Group