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

Surgery Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004627
• Other study ID #: Access 1
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: January 2012

Study information

• Verified date: July 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Failure
• Fistula
• Kidney Failure, Chronic
• Renal Insufficiency
• Surgery

Intervention

Procedure:
• Arterial and venous duplex ultrasound examination
Ultrasound mapping of all blood vessels in the upper limb of interest

Locations

Country	Name	City	State
United Kingdom	Hull Royal Infirmary	Hull

Sponsors (2)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust	University of Hull

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microparticle concentration	Blood tests will be taken at baseline, 1, 3 and 6 months to investigate the impact of concentrations on patency	open
Other	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
Primary	Primary failure of access (immediate/early thrombosis or failure to mature).		30 days
Secondary	Assisted primary patency - being the interval from placement until the time of measurement of patency, including intervening manipulations		open ended
Secondary	Secondary patency - The interval from placement until time of patency measurement including intervening manipulations		open ended
Secondary	Site of fistula created		within 1 month of recruitment
Secondary	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
Secondary	Surgeon grade		open ended

External Links

•   Publication Link