Surveillance and Proactive Intervention for Dialysis Access (SPIDA)

March 18, 2021 updated by: University of Hull

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.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surveillance and proactive intervention
Procedure: Active ultrasound surveillance of fistula and proactive treatment of stenosis
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
No Intervention: Control and reactive intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative or secondary patency
Time Frame: within 6 months of fistula formation
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.
within 6 months of fistula formation

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of thrombosis events
Time Frame: within 6 months of fistula formation
within 6 months of fistula formation
Number of fistula failures
Time Frame: within 6 months of fistula formation
within 6 months of fistula formation
Number, type and technical success rate for elective interventions
Time Frame: within 6 months of fistula formation
within 6 months of fistula formation
Number, type and technical success rate of acute interventions
Time Frame: within 6 months of fistula formation
within 6 months of fistula formation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hull

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Access 6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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