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Completed

NCT Number: NCT01685710

The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

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.

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Key information

Conditions

Renal Failure Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Queen Elizabeth Hospital, Birmingham.

Birmingham, West Midlands, B15 2TH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GTN patch

Drug

Other names: Minitran 5

placebo comparator

Drug

This arm will be a placebo patch to the active drug patch to blind the trial.

Primary outcomes

  1. Change to diameter of vein

    Time frame: 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 outcomes

  1. Number of participants with adverse events

    Time frame: 6 weeks

    Those receiving the active patch will be compared with those receiving the placebo patch for adverse events

Sponsors and collaborators

Lead sponsor

University Hospital Birmingham

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 14, 2012
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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