Clinical Trial: Trial Comparing the Incidence of Steal Syndrome in the Two Types of anTEcubitaL Fossa Arteriovenous fistuLa AVF

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomised Controlled Trial Comparing the Incidence of Steal Syndrome in the Two Types of anTEcubitaL Fossa Arteriovenous fistuLa AVF (STEAL Trial)

Brief Summary:

Background:

Arteriovenous fistula (AVF) is a form of vascular access for haemodialysis. An AVF is normally created at the level of the wrist, but occasionally it is created in the elbow when there is no suitable vessel in the forearm. The most common type of elbow (antecubital) fistula (AFF) is a brachiocephalic fistula, which carries significantly higher risk of steal syndrome (AVF-associated hand ischaemia) than wrist fistulas. More recently, AFF using proximal radial or ulnar artery as inflow has been described and shown to have a lower rate of Steal syndrome than brachiocephalic fistula. This study aims to investigate the incidence of steal syndrome between AFF using brachial artery and that using the proximal radial/ulnar artery as inflow.


Detailed Summary:

Arteriovenous fistulas (AVF) are the safest form of vascular access for long-term haemodialysis in patients with end-stage renal failure. The strategy in creating an AVF in the upper limbs is to start at a distal site and if that fails, to attempt an AVF on a more proximal site i.e. from wrist, forearm to elbow. The most common type of AVF is the radiocephalic AVF at the wrist. A more proximal AVF is often created as a primary procedure when there is poor vasculature in the distal forearm or as a secondary procedure when a wrist fistula has failed. Traditionally, brachiocephalic fistulas (BCF), which involves anastomosing the cephalic vein to the brachial artery, have been the most common type of AVF created in the antecubital fossa at the elbow level. Other common types of antecubital fossa arteriovenous fistula (AFF) are the brachiobasilic (BBF) and brachio-median cubital AVF.

Steal syndrome relates to hand ischaemia associated with AVF creation, and is a major risk of AVF formation. The symptoms of steal syndrome ranges from cold extremities, numbness, hand claudication (pain after exercise), to rest pain and tissue loss. Steal syndrome can also be measured by Digital Brachial Pressure Index. Severe steal syndrome is debilitating, and limb-threatening, and requires surgical revision or ligation of the AVF. This leads to additional surgical risks and loss of dialysis vascular access.

Diabetes and the types of AVF have been found to be independent risk factors for developing steal syndrome following AVF creation1. The highest risk is seen in patients with a proximal AVF i.e. BCF/BBF; up to 50% of patients in some studies, compared to 5-8% in all upper limb AVFs.

An alternative technique that may reduce risk of steal in this group of patients is to anastomose the vein to th
Sponsor: Cambridge University Hospitals NHS Foundation Trust

Current Primary Outcome: Incidence of steal syndrome as measured by Hoek Score [ Time Frame: 6 months ]

Determine the incidence of steal syndrome in the 2 arms of the study


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Presence of severe steal syndrome necessitating surgical revision/ligation [ Time Frame: 6 months ]
    Determine the presence of severe steal syndrome necessitating surgical revision/ligation
  • Operative time [ Time Frame: 6 months ]
    Determine the efficacy of the two study interventions in terms of operative time.
  • Utilisation of fistula [ Time Frame: 6 months ]
    Determine the efficacy of the two study interventions in terms of utilisation.


Original Secondary Outcome: Same as current

Information By: Cambridge University Hospitals NHS Foundation Trust

Dates:
Date Received: October 29, 2014
Date Started: February 2011
Date Completion: December 2017
Last Updated: June 29, 2015
Last Verified: June 2015