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

Not Applicable

Completed

• Conditions: End Stage Renal Failure; Surgery
• Interventions: Procedure: Arterial and venous duplex ultrasound examination

• Registration Number: NCT01004627
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

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.

Study Timeline

• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Study Start: 2010-03
• Primary Completion: 2011-11
• Study Completion: 2012-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obligatory Duplex scan	Arterial and venous duplex ultrasound examination	Patients will receive a duplex ultrasound regardless of clinical findings. Arterial and venous duplex ultrasound examination

Primary Outcome Measures

Name	Time	Method
Primary failure of access (immediate/early thrombosis or failure to mature).	30 days

Secondary Outcome Measures

Name	Time	Method
Site of fistula created	within 1 month of recruitment
Surgeon grade	open ended
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
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

Trial Locations

Locations (1)

Hull Royal Infirmary; 🇬🇧 Hull, United Kingdom