The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

University Hospitals Birmingham NHS Foundation Trust (UHB)

Status and phase: Completed; Phase 4

Conditions: Renal Failure

Treatments: Drug: placebo comparator; Drug: GTN patch

Study type: Interventional

Funder types: Other

Identifiers

NCT01685710

RRK4178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

GTN patch

Experimental group

Description:

GTN patch 5mg, in situ 24hrs

Treatment:

Drug: GTN patch

Placebo patch

Placebo Comparator group

Description:

Placebo patch, in situ for 24hrs

Treatment:

Drug: placebo comparator