The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

Phase 4

Completed

• Conditions: Renal Failure
• Interventions: Drug: placebo comparator; Drug: GTN patch

• Registration Number: NCT01685710
• Lead Sponsor: University Hospital Birmingham

Brief Summary

The aim of the study is to determine whether the application of a glyceryl trinitrate patch (GTN patch) helps arteriovenous fistulas, created for renal dialysis access, mature so that they can be used.

Detailed Description

Patients with end stage renal failure on haemodialysis must have a mechanism for achieving access to their vascular system for dialysis. Arteriovenous fistulas (surgically created connections between the artery and vein) are critical for the majority of patients. Not all the fistulas that are created work, a proportion fail early on and need to be revised or an alternative fistula created. A recent multicentre study demonstrated a 40% primary failure rate(1). In an attempt to increase the numbers of fistulae that reach maturation sufficient for dialysis access cannulation some renal centres apply GTN patches to the fistula at the time of surgery. It is thought that this works by increasing the size of the blood vessels and promoting blood flow through them and some preliminary work seems to support this(2).

The evidence for the use of GTN patches in arteriovenous fistula creation is theoretical or based on preliminary work rather than robust evidence. Similarly no evidence exists within the literature to determine the safety and definite efficacy of this procedure in this population. We propose to conduct a double-blinded randomised control trial to answer the study question: does the application of a GTN patch increase the venous outflow diameter post fistula formation and does this result in improved fistula patency.

Study Timeline

• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-14
• Study Start: 2013-04
• Primary Completion: 2015-05
• Status Verified: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Primary arteriovenous fistulas

  • Brachiocephalic
  • Radiocephalic (both proximal and distal)

• >18 yrs old

• Diabetics and smokers will be eligible for inclusion

Exclusion Criteria

• All complex vascular access procedures

  • Re-do brachiocephalic and radiocephalic fistulas
  • Brachiobasilic fistulas
  • Prosthetic grafts

• Cardiovascular dysfunction

  • Hypotension (systolic <90)
  • Obstructive Cardiomyopathy
  • Severe Aortic stenosis (gradient >40mmhg)
  • Confirmed myocardial infarction within the last 6 months

• Marked anaemia (Hb<8)

• Migraine

• Medications

  • Sildenafil
  • Pre-existing nitrate use

• Nitrate allergy

• Closed-angle glaucoma

• Chronically raised intra-cranial pressure

• History of hypothyroid disease

• < 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo patch	placebo comparator	Placebo patch, in situ for 24hrs
GTN patch	GTN patch	GTN patch 5mg, in situ 24hrs

Primary Outcome Measures

Name	Time	Method
Change to diameter of vein	Initial assessment and 6 weeks after surgery	At initial assessment of the vein the size will be recorded for later comparison. This will then be re-assessed at 6 weeks post-surgery to allow the change in venous diameter to be assessed.

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	6 weeks	Those receiving the active patch will be compared with those receiving the placebo patch for adverse events

Trial Locations

Locations (1)

Queen Elizabeth Hospital, Birmingham.; 🇬🇧 Birmingham, West Midlands, United Kingdom