Back to resultsSurveillance and Proactive Intervention for Dialysis Access (SPIDA)
Primary Purpose
Renal Failure, Arteriovenous Fistula
Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Active ultrasound surveillance of fistula and proactive treatment of stenosis
Sponsored by
About this trial
This is an interventional prevention trial for Renal Failure focused on measuring arteriovenous fistula, surveillance, arterial stenosis, venous stenosis
Eligibility Criteria
Inclusion Criteria:
- Incident patients referred to vascular or transplant surgery departments for primary AV fistula formation for haemodialysis access.
- Ability to give informed written consent
- Aged over 18 at time of referral
Exclusion Criteria:
- Inability to give informed written consent
- Aged under 18 at time of referral
- Inability to attend follow-up appointments
Specific exclusion;
- Previous arteriovenous access procedures in target limb
- Unsuitable for upper limb radiocephalic or brachiocephalic AVF formation
- Known thrombophilic or thrombotic pathology
Sites / Locations
- Hull Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Surveillance and proactive intervention
Control and reactive intervention
Arm Description
Outcomes
Primary Outcome Measures
Cumulative or secondary patency
This being the interval from the time of access placement until access abandonment, thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access.
Secondary Outcome Measures
Number of thrombosis events
Number of fistula failures
Number, type and technical success rate for elective interventions
Number, type and technical success rate of acute interventions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01391975
Brief Title
Surveillance and Proactive Intervention for Dialysis Access
Acronym
SPIDA
Official Title
A Multi Centre Randomized Controlled Trial of the Clinical and Cost Effectiveness of Duplex Ultrasound Surveillance With Proactive Intervention Versus no Surveillance and Reactive Intervention for the Management of Stenosis in Arterio-venous Fistulae for Dialysis Vascular Access.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hull
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Newly formed dialysis fistulae can often fail, and failure is usually due to narrowing of the blood vessels. Methods of detecting narrowing are available and, more importantly, can detect narrowings before a fistula fails. It is not known whether treating these narrowings will actually improve fistula survival or if the majority can be left alone. we wish to see if we can detect such narrowings with ultrasound scanning and if early detection and treatment improves patient outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Arteriovenous Fistula
Keywords
arteriovenous fistula, surveillance, arterial stenosis, venous stenosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surveillance and proactive intervention
Arm Type
Experimental
Arm Title
Control and reactive intervention
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Active ultrasound surveillance of fistula and proactive treatment of stenosis
Intervention Description
Regular duplex ultrasound assessment of fistula from time of creation until 6 months post procedure with referral of all haemodynamically significant stenoses to further imaging and treatment
Primary Outcome Measure Information:
Title
Cumulative or secondary patency
Description
This being the interval from the time of access placement until access abandonment, thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access.
Time Frame
within 6 months of fistula formation
Secondary Outcome Measure Information:
Title
Number of thrombosis events
Time Frame
within 6 months of fistula formation
Title
Number of fistula failures
Time Frame
within 6 months of fistula formation
Title
Number, type and technical success rate for elective interventions
Time Frame
within 6 months of fistula formation
Title
Number, type and technical success rate of acute interventions
Time Frame
within 6 months of fistula formation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Incident patients referred to vascular or transplant surgery departments for primary AV fistula formation for haemodialysis access.
Ability to give informed written consent
Aged over 18 at time of referral
Exclusion Criteria:
Inability to give informed written consent
Aged under 18 at time of referral
Inability to attend follow-up appointments
Specific exclusion;
Previous arteriovenous access procedures in target limb
Unsuitable for upper limb radiocephalic or brachiocephalic AVF formation
Known thrombophilic or thrombotic pathology
Facility Information:
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Surveillance and Proactive Intervention for Dialysis Access
We'll reach out to this number within 24 hrs