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

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.

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.

Study Overview

• Status: Completed
• Conditions: Surgery; End Stage Renal Failure
• Intervention / Treatment: Procedure: Arterial and venous duplex ultrasound examination

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
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hull, United Kingdom, HU3 2JZ
    • Hull Royal Infirmary

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary failure of access (immediate/early thrombosis or failure to mature).	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Assisted primary patency - being the interval from placement until the time of measurement of patency, including intervening manipulations	open ended
Secondary patency - The interval from placement until time of patency measurement including intervening manipulations	open ended
Site of fistula created	within 1 month of recruitment
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.	open ended
Surgeon grade	open ended

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microparticle concentration	Blood tests will be taken at baseline, 1, 3 and 6 months to investigate the impact of concentrations on patency	open
Circulating tissue factor concentration	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	open

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust
• Collaborators: University of Hull
• Investigators: Principal Investigator: Ian C Chetter, MBChB FRCS MD, Hull University

Publications and helpful links

General Publications

• Smith GE, Barnes R, Chetter IC. Randomized clinical trial of selective versus routine preoperative duplex ultrasound imaging before arteriovenous fistula surgery. Br J Surg. 2014 Apr;101(5):469-74. doi: 10.1002/bjs.9435. Epub 2014 Feb 20.

Helpful Links

• Publication Link

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 29, 2009
• First Submitted That Met QC Criteria: October 29, 2009
• First Posted (Estimate): October 30, 2009

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: ultrasound; fistula; Haemodialysis; angioaccess; preoperative vein mapping; Angioaccess surgery
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Fistula
• Other Study ID Numbers: Access 1