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Surveillance and Proactive Intervention for Dialysis Access (SPIDA)

This study is not yet open for participant recruitment.
Verified July 2011 by University of Hull
Sponsor:
Information provided by:
University of Hull
ClinicalTrials.gov Identifier:
NCT01391975
First received: July 11, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Dialysis Fistulas
U.S. FDA Resources

Further study details as provided by University of Hull:

Primary Outcome Measures:
  • Cumulative or secondary patency [ Time Frame: within 6 months of fistula formation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of fistula failures [ Time Frame: within 6 months of fistula formation ] [ Designated as safety issue: No ]
  • Number, type and technical success rate for elective interventions [ Time Frame: within 6 months of fistula formation ] [ Designated as safety issue: No ]
  • Number, type and technical success rate of acute interventions [ Time Frame: within 6 months of fistula formation ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ian Chetter, Hull and York Medical School
ClinicalTrials.gov Identifier: NCT01391975     History of Changes
Other Study ID Numbers: Access 6
Study First Received: July 11, 2011
Last Updated: July 11, 2011
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on June 17, 2013