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Surveillance 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Withdrawn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
University of Hull
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Failure focused on measuring arteriovenous fistula, surveillance, arterial stenosis, venous stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Incident patients referred to vascular or transplant surgery departments for primary AV fistula formation for haemodialysis access.
  2. Ability to give informed written consent
  3. Aged over 18 at time of referral

Exclusion Criteria:

  1. Inability to give informed written consent
  2. Aged under 18 at time of referral
  3. Inability to attend follow-up appointments

Specific exclusion;

  1. Previous arteriovenous access procedures in target limb
  2. Unsuitable for upper limb radiocephalic or brachiocephalic AVF formation
  3. 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

First Posted
July 11, 2011
Last Updated
March 18, 2021
Sponsor
University of Hull
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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

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