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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Hull.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Hull
ClinicalTrials.gov Identifier:
NCT01004627
First received: October 29, 2009
Last updated: July 19, 2011
Last verified: May 2010
History of Changes
  Purpose

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 Intervention Phase
Haemodialysis
Surgery
 Procedure: Arterial and venous duplex ultrasound examination
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Hull:

Primary Outcome Measures:
  • Primary failure of access (immediate/early thrombosis or failure to mature). [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assisted primary patency - being the interval from placement until the time of measurement of patency, including intervening manipulations [ Time Frame: open ended ] [ Designated as safety issue: No ]
  • Secondary patency - The interval from placement until time of patency measurement including intervening manipulations [ Time Frame: open ended ] [ Designated as safety issue: No ]
  • Site of fistula created [ Time Frame: within 1 month of recruitment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group - selective duplex
Patients will receive a duplex ultrasound only if specifically requested following physical examination.
 Procedure: Arterial and venous duplex ultrasound examination
Ultrasound mapping of all blood vessels in the upper limb of interest
Experimental: Obligatory Duplex scan
Patients will receive a duplex ultrasound regardless of clinical findings.
 Procedure: Arterial and venous duplex ultrasound examination
Ultrasound mapping of all blood vessels in the upper limb of interest

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004627

Contacts
Contact: George E Smith, MBBS MRCS 01482 675523 george.smith@hey.nhs.uk
Contact: Ian C Chetter, MBChB MD FRCS 01482665523 ian.chetter@hey.nhs.uk

Locations
United Kingdom
Hull Royal Infirmary Recruiting
Hull, United Kingdom, HU3 2JZ
Contact: George E Smith, BSc MBBS MRCS     01482 675523     george.smith@hey.nhs.uk    
Contact: Ian C Chetter, MBChB FRCS MD     01482 674765     ian.chetter@hey.nhs.uk    
Sub-Investigator: George E Smith, BSc MBBS MRCS            
Principal Investigator: Ian C Chetter, MBChB FRCS MD            
Sponsors and Collaborators
University of Hull
Investigators
Principal Investigator: Ian C Chetter, MBChB FRCS MD Hull University
  More Information

No publications provided

Responsible Party: Mr IC Chetter, Hull University
ClinicalTrials.gov Identifier: NCT01004627     History of Changes
Other Study ID Numbers: Access 1
Study First Received: October 29, 2009
Last Updated: July 19, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Hull:
fistula
ultrasound
angioaccess
 preoperative vein mapping
Haemodialysis
Angioaccess surgery

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

ClinicalTrials.gov processed this record on May 22, 2013