Back to resultsA Study of Routine Versus Selective Use of Ultrasound Scanning Prior to Haemodialysis Fistula Surgery
Primary Purpose
End Stage Renal Failure, Surgery
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Arterial and venous duplex ultrasound examination
Sponsored by
About this trial
This is an interventional other trial for End Stage Renal Failure focused on measuring fistula, ultrasound, angioaccess, preoperative vein mapping, Haemodialysis, Angioaccess surgery
Eligibility 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
Sites / Locations
- Hull Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group - selective duplex
Obligatory Duplex scan
Arm Description
Patients will receive a duplex ultrasound only if specifically requested following physical examination.
Patients will receive a duplex ultrasound regardless of clinical findings. Arterial and venous duplex ultrasound examination
Outcomes
Primary Outcome Measures
Primary failure of access (immediate/early thrombosis or failure to mature).
Secondary Outcome Measures
Assisted primary patency - being the interval from placement until the time of measurement of patency, including intervening manipulations
Secondary patency - The interval from placement until time of patency measurement including intervening manipulations
Site of fistula created
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.
Surgeon grade
Full Information
NCT ID
NCT01004627
First Posted
October 29, 2009
Last Updated
July 10, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
University of Hull
1. Study Identification
Unique Protocol Identification Number
NCT01004627
Brief Title
A Study of Routine Versus Selective Use of Ultrasound Scanning Prior to Haemodialysis Fistula Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
University of Hull
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure, Surgery
Keywords
fistula, ultrasound, angioaccess, preoperative vein mapping, Haemodialysis, Angioaccess surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group - selective duplex
Arm Type
No Intervention
Arm Description
Patients will receive a duplex ultrasound only if specifically requested following physical examination.
Arm Title
Obligatory Duplex scan
Arm Type
Experimental
Arm Description
Patients will receive a duplex ultrasound regardless of clinical findings. Arterial and venous duplex ultrasound examination
Intervention Type
Procedure
Intervention Name(s)
Arterial and venous duplex ultrasound examination
Intervention Description
Ultrasound mapping of all blood vessels in the upper limb of interest
Primary Outcome Measure Information:
Title
Primary failure of access (immediate/early thrombosis or failure to mature).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Assisted primary patency - being the interval from placement until the time of measurement of patency, including intervening manipulations
Time Frame
open ended
Title
Secondary patency - The interval from placement until time of patency measurement including intervening manipulations
Time Frame
open ended
Title
Site of fistula created
Time Frame
within 1 month of recruitment
Title
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
Title
Surgeon grade
Time Frame
open ended
Other Pre-specified Outcome Measures:
Title
Microparticle concentration
Description
Blood tests will be taken at baseline, 1, 3 and 6 months to investigate the impact of concentrations on patency
Time Frame
open
Title
Circulating tissue factor concentration
Description
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
Time Frame
open
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian C Chetter, MBChB FRCS MD
Organizational Affiliation
Hull University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24756913
Citation
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.
Results Reference
result
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A Study of Routine Versus Selective Use of Ultrasound Scanning Prior to Haemodialysis Fistula Surgery
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