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

NCT02297451 | Completed

• 2 other identifiers: A09198210/H0308/90
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Fistulas; Renal Failure, End-Stage; Steal Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of steal syndrome as measured by Hoek Score

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

  6 months

Secondary Outcomes (3)

• Presence of severe steal syndrome necessitating surgical revision/ligation

  6 months

• Operative time

  6 months

• Utilisation of fistula

  6 months

Study Arms (2)

Brachial artery inflow

NO INTERVENTION

Elbow fistula created with brachial artery as inflow (ie. either brachiocephalic or brachiobasilic fistulas)

Proximal radial/ulnar artery as inflow

ACTIVE COMPARATOR

Elbow fistula created with either proximal radial or ulnar artery as inflow

Procedure: Proximal radial/ulnar artery as inflow

Interventions

Proximal radial/ulnar artery as inflow PROCEDURE

Proximal radial/ulnar artery used as inflow

Proximal radial/ulnar artery as inflow

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End stage renal failure Requiring AVF at in the antecubital fossa for haemodialysis

You may not qualify if:

• When the participant has not received the allocated intervention due to anatomical anomaly, technical issue or any other reason

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Gavin Pettigrew, MD, FRCS

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: November 21, 2014
• Study Start: February 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

GB (1)