The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

This study is not yet open for participant recruitment.
Verified September 2012 by University Hospital Birmingham
Sponsor:
Information provided by (Responsible Party):
Mr Nick Inston, University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT01685710
First received: August 30, 2012
Last updated: September 11, 2012
Last verified: September 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University Hospital Birmingham:

Primary Outcome Measures:
  • Change to diameter of vein [ Time Frame: Initial assessment and 6 weeks after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Those receiving the active patch will be compared with those receiving the placebo patch for adverse events


Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Primary Completion Date: October 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685710

Contacts
Contact: Nicholas G Inston, FRCS +44 121 371 2000 nicholas.inston2@uhb.nhs.uk
Contact: Melanie A Field, MRCS +44 121 371 2000 melfield@doctors.org.uk

Locations
United Kingdom
Queen Elizabeth Hospital, Birmingham. Not yet recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Sub-Investigator: Melanie A Field, MRCS         
Sponsors and Collaborators
University Hospital Birmingham
Investigators
Principal Investigator: Nicholas G Inston, FRCS University Hospital Birmingham, UK.
  More Information

Publications:
Responsible Party: Mr Nick Inston, Consultant Surgeon, University Hospital Birmingham
ClinicalTrials.gov Identifier: NCT01685710     History of Changes
Other Study ID Numbers: RRK4178
Study First Received: August 30, 2012
Last Updated: September 11, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospital Birmingham:
Arteriovenous fistula
Patency
GTN patch

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

ClinicalTrials.gov processed this record on April 15, 2014