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Surveillance and Proactive Intervention for Dialysis Access (SPIDA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by University of Hull.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01391975
First Posted: July 12, 2011
Last Update Posted: July 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Hull
  Purpose
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.

Condition Intervention
Renal Failure Arteriovenous Fistula Procedure: Active ultrasound surveillance of fistula and proactive treatment of stenosis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by University of Hull:

Primary Outcome Measures:
  • 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.


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

Estimated Enrollment: 850
Study Start Date: May 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391975


Contacts
Contact: Ian C Chetter, MBChB, MD, FRCS 01482 674765 ian.chetter@hey.nhs.uk
Contact: George E Smith, BSc, MBBS, MRCS george.smith@hey.nhs.uk

Locations
United Kingdom
Hull Royal Infirmary Not yet recruiting
Hull, United Kingdom, HU3 2JZ
Contact: Ian C Chetter, MBChB, MD, FRCS       ian.chetter@hey.nhs.uk   
Contact: George E Smith, BSc, MBBS, MRCS       george.smith@hey.nhs.uk   
Principal Investigator: Ian C Chetter, MBChB, MD, FRCS         
Sponsors and Collaborators
University of Hull
  More Information

Responsible Party: Ian Chetter, Hull and York Medical School
ClinicalTrials.gov Identifier: NCT01391975     History of Changes
Other Study ID Numbers: Access 6
First Submitted: July 11, 2011
First Posted: July 12, 2011
Last Update Posted: July 12, 2011
Last Verified: July 2011

Keywords provided by University of Hull:
arteriovenous fistula
surveillance
arterial stenosis
venous stenosis

Additional relevant MeSH terms:
Arteriovenous Fistula
Renal Insufficiency
Fistula
Kidney Diseases
Urologic Diseases
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities