Clinical trial NCT01004627: 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
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Failure
Surgery
Keywords: fistula
ultrasound
angioaccess
preoperative vein mapping
Haemodialysis
Angioaccess surgery
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Hull
First posted: 2009-10-30
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Primary failure of access (immediate/early thrombosis or failure to mature).
timeFrame: 30 days
Secondary outcomes:
measure: Assisted primary patency - being the interval from placement until the time of measurement of patency, including intervening manipulations
timeFrame: open ended
measure: Secondary patency - The interval from placement until time of patency measurement including intervening manipulations
timeFrame: open ended
measure: Site of fistula created
timeFrame: within 1 month of recruitment
measure: 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.
timeFrame: open ended
measure: Surgeon grade
timeFrame: open ended
Other outcomes:
measure: Microparticle concentration
timeFrame: open
measure: Circulating tissue factor concentration
timeFrame: open
Locations:
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
Study officials:
affiliation: Hull University
name: Ian C Chetter, MBChB FRCS MD
role: PRINCIPAL_INVESTIGATOR
References:
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.