The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University Hospital Birmingham.
Recruitment status was  Not yet recruiting
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

August 30, 2012
September 11, 2012
October 2012
October 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01685710 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Renal Failure
  • Drug: GTN patch
    Other Name: Minitran 5
  • Drug: placebo comparator
    This arm will be a placebo patch to the active drug patch to blind the trial.
  • Experimental: GTN patch
    GTN patch 5mg, in situ 24hrs
    Intervention: Drug: GTN patch
  • Placebo Comparator: Placebo patch
    Placebo patch, in situ for 24hrs
    Intervention: Drug: placebo comparator

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
Not Provided
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
United Kingdom
 
NCT01685710
RRK4178
Yes
Mr Nick Inston, University Hospital Birmingham
University Hospital Birmingham
Not Provided
Principal Investigator: Nicholas G Inston, FRCS University Hospital Birmingham, UK.
University Hospital Birmingham
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP