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.
|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|
- 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.
- 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
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685710
|Contact: Nicholas G Inston, FRCS||+44 121 371 firstname.lastname@example.org|
|Contact: Melanie A Field, FRCS||+44 121 371 email@example.com|
|Queen Elizabeth Hospital, Birmingham.||Recruiting|
|Birmingham, West Midlands, United Kingdom, B15 2TH|
|Contact: Nicholas Inston, FRCS 01213712000|
|Sub-Investigator: Melanie A Field, FRCS|
|Principal Investigator:||Nicholas G Inston, FRCS||University Hospital Birmingham, UK.|