A Study of Routine Versus Selective Use of Ultrasound Scanning Prior to Haemodialysis Fistula Surgery

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. Identifier: NCT01004627
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : June 2, 2014
Information provided by (Responsible Party):
Daniel Carradice, University of Hull

Brief Summary:
Dialysis patients have their blood filtered by a machine as their kidneys no longer work. To get blood in and out of these patients it is possible to perform a surgical procedure to increase to size and durability of a vein in the arm to allow repeated needle insertion. This enlarged vein is called a fistula. There is some evidence that ultrasound scanning the blood vessels in the arm before surgery can improve the chances of a successful procedure. The investigators aim to test whether scanning all patients is better than scanning only those who are difficult to assess by physical examination alone.

Condition or disease Intervention/treatment Phase
End Stage Renal Failure Surgery Procedure: Arterial and venous duplex ultrasound examination Phase 4

Detailed Description:
We will recruit all patients undergoing primary vascular access procedures in our unit who meet inclusion criteria. They will be randomised to either surgery based on clinical findings with duplex ultrasound only if requested by surgeon, or routine duplex ultrasound prior to surgery.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial of the Clinical Effectiveness of Obligatory Versus Elective Duplex Ultrasound Scanning Prior to Arteriovenous Fistula Formation for Haemodialysis Vascular Access in a University Teaching Hospital.
Study Start Date : March 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control group - selective duplex
Patients will receive a duplex ultrasound only if specifically requested following physical examination.
Experimental: Obligatory Duplex scan
Patients will receive a duplex ultrasound regardless of clinical findings. Arterial and venous duplex ultrasound examination
Procedure: Arterial and venous duplex ultrasound examination
Ultrasound mapping of all blood vessels in the upper limb of interest

Primary Outcome Measures :
  1. Primary failure of access (immediate/early thrombosis or failure to mature). [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Assisted primary patency - being the interval from placement until the time of measurement of patency, including intervening manipulations [ Time Frame: open ended ]
  2. Secondary patency - The interval from placement until time of patency measurement including intervening manipulations [ Time Frame: open ended ]
  3. Site of fistula created [ Time Frame: within 1 month of recruitment ]
  4. Functional primary patency - being the interval from the time of access placement until any intervention designed to maintain or re-establish patency or the time of measurement of patency during which the AVF provides dialysis access. [ Time Frame: open ended ]
  5. Surgeon grade [ Time Frame: open ended ]

Other Outcome Measures:
  1. Microparticle concentration [ Time Frame: open ]
    Blood tests will be taken at baseline, 1, 3 and 6 months to investigate the impact of concentrations on patency

  2. Circulating tissue factor concentration [ Time Frame: open ]
    Blood test to be taken at baseline, 1, 3 and 6 months and examined using ELISA to establish the impact of tissue factor concentrations on patency

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

Inclusion Criteria:

  • Specific inclusion criteria necessary for invitation to study participation; Patients referred to vascular consultants for primary AV fistula formation (or primary fistula in that limb) for haemodialysis access.

General inclusion criteria;

  • Ability to give informed written consent

Exclusion Criteria:

  • Specific exclusion criteria;

    • Previous arterial or venous surgery/intervention performed on target limb.
    • Known thrombophilic or thrombotic pathology.
    • Aged under 18 at time of referral

General exclusion criteria;

  • Inability to give informed written consent
  • Inability to attend follow up appointments

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 identifier (NCT number): NCT01004627

United Kingdom
Hull Royal Infirmary
Hull, United Kingdom, HU3 2JZ
Sponsors and Collaborators
University of Hull
Principal Investigator: Ian C Chetter, MBChB FRCS MD Hull University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Daniel Carradice, DCarradice, University of Hull Identifier: NCT01004627     History of Changes
Other Study ID Numbers: Access 1
First Posted: October 30, 2009    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014

Keywords provided by Daniel Carradice, University of Hull:
preoperative vein mapping
Angioaccess surgery

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Pathological Conditions, Anatomical
Renal Insufficiency, Chronic