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出境医 / 临床实验 / Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis (VALID)

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

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
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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 612 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 : December 6, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  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. [ 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


Secondary Outcome Measures :
  1. Rate of vascular access interventions to enable and maintain the use of a vascular access for haemodialysis (number/patient-year). [ Time Frame: 6 months ]
    Interventions collected as listed in the Primary Outcome description

  2. Time to first vascular access intervention to enable and maintain the use of a vascular access for haemodialysis (days). [ Time Frame: 6 months ]
    Interventions collected as listed in the Primary Outcome description

  3. Type of vascular access interventions. [ Time Frame: 6 months ]
    Interventions collected as listed in the Primary Outcome description


Other Outcome Measures:
  1. Time required for measuring vascular access function (minutes) [ Time Frame: 6 months ]
    Feasibility outcome measures

  2. Completeness of data collection (percentage) [ Time Frame: 6 months ]
    Feasibility outcome measures

  3. Likert score of feasibility questionnaire with data collectors (scale of 1 to 5, 1=strongly disagree, 5=strongly agree) [ Time Frame: 6 months ]
    Feasibility outcome measures

  4. Qualitative analysis of semi structured interview with data collector [ Time Frame: 6 months ]
    Feasibility outcome measures

  5. Recruitment rate (number of participants/year) [ Time Frame: 6 months ]
    Feasibility outcome measures

  6. Eligibility ratio (number of patients eligible/number of patients screened) [ Time Frame: 6 months ]
    Feasibility outcome measures

  7. Enrolment ratio (number of patients enrolled/number of patients screened) [ Time Frame: 6 months ]
    Feasibility outcome measures


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Layout table for location information
United States, Pennsylvania
Dialysis Clinic, Inc. Canterbury
Pittsburgh, Pennsylvania, United States, 15224
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4110
Australia
Mater Hospital
Brisbane, Australia
Hervey Bay Hospital
Hervey Bay, Australia
Canada
University Health Network
Toronto, Canada
France
Centre Hospitalier Régional Universitaire de Tours
Tours, France
Malaysia
Hospital Sultanah Aminah Johor Bahru
Johor Bahru, Malaysia
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Switzerland
Ospedale Regionale di Lugano
Lugano, Switzerland
United Kingdom
Sheffield Teaching Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
The University of Queensland
Australasian Kidney Trials Network
Investigators
Layout table for investigator information
Principal Investigator: Andrea Viecelli, MD, FRAC Princess Alexandra Hospital and Australasian Kidney Trials Network
Tracking Information
First Submitted Date May 10, 2019
First Posted Date May 31, 2019
Last Update Posted Date September 10, 2020
Actual Study Start Date December 6, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2019) 		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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 28, 2019)
  • Rate of vascular access interventions to enable and maintain the use of a vascular access for haemodialysis (number/patient-year). [ Time Frame: 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). [ Time Frame: 6 months ]
    Interventions collected as listed in the Primary Outcome description
  • Type of vascular access interventions. [ Time Frame: 6 months ]
    Interventions collected as listed in the Primary Outcome description
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 28, 2019)
  • Time required for measuring vascular access function (minutes) [ Time Frame: 6 months ]
    Feasibility outcome measures
  • Completeness of data collection (percentage) [ Time Frame: 6 months ]
    Feasibility outcome measures
  • Likert score of feasibility questionnaire with data collectors (scale of 1 to 5, 1=strongly disagree, 5=strongly agree) [ Time Frame: 6 months ]
    Feasibility outcome measures
  • Qualitative analysis of semi structured interview with data collector [ Time Frame: 6 months ]
    Feasibility outcome measures
  • Recruitment rate (number of participants/year) [ Time Frame: 6 months ]
    Feasibility outcome measures
  • Eligibility ratio (number of patients eligible/number of patients screened) [ Time Frame: 6 months ]
    Feasibility outcome measures
  • Enrolment ratio (number of patients enrolled/number of patients screened) [ Time Frame: 6 months ]
    Feasibility outcome measures
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis
Official Title Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis (VALID)
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.
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Vascular Access Complication
  • Hemodialysis Access Failure (Disorder)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 28, 2019) 		612
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada,   France,   Malaysia,   Netherlands,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03969225
Other Study ID Numbers AKTN 19.01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (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.
Responsible Party The University of Queensland
Study Sponsor The University of Queensland
Collaborators Australasian Kidney Trials Network
Investigators
Principal Investigator: Andrea Viecelli, MD, FRAC Princess Alexandra Hospital and Australasian Kidney Trials Network
PRS Account The University of Queensland
Verification Date September 2020

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