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The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01685710
First Posted: September 14, 2012
Last Update Posted: June 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mr Nick Inston, University Hospital Birmingham
  Purpose
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.

Condition Intervention Phase
Renal Failure Drug: GTN patch Drug: placebo comparator Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

Resource links provided by NLM:


Further study details as provided by Mr Nick Inston, University Hospital Birmingham:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 200
Study Start Date: April 2013
Study Completion Date: June 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GTN patch
GTN patch 5mg, in situ 24hrs
Drug: GTN patch
Other Name: Minitran 5
Placebo Comparator: Placebo patch
Placebo patch, in situ for 24hrs
Drug: placebo comparator
This arm will be a placebo patch to the active drug patch to blind the trial.

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685710


Locations
United Kingdom
Queen Elizabeth Hospital, Birmingham.
Birmingham, West Midlands, United Kingdom, B15 2TH
Sponsors and Collaborators
University Hospital Birmingham
Investigators
Principal Investigator: Nicholas G Inston, FRCS University Hospital Birmingham, UK.
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mr Nick Inston, Consultant Surgeon, University Hospital Birmingham
ClinicalTrials.gov Identifier: NCT01685710     History of Changes
Other Study ID Numbers: RRK4178
First Submitted: August 30, 2012
First Posted: September 14, 2012
Last Update Posted: June 2, 2015
Last Verified: June 2015

Keywords provided by Mr Nick Inston, University Hospital Birmingham:
Arteriovenous fistula
Patency
GTN patch

Additional relevant MeSH terms:
Arteriovenous Fistula
Renal Insufficiency
Fistula
Kidney Diseases
Urologic Diseases
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Nitroglycerin
Vasodilator Agents