The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas
|ClinicalTrials.gov Identifier: NCT01685710|
Recruitment Status : Completed
First Posted : September 14, 2012
Last Update Posted : June 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Renal Failure||Drug: GTN patch Drug: placebo comparator||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||June 2015|
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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685710
|Queen Elizabeth Hospital, Birmingham.|
|Birmingham, West Midlands, United Kingdom, B15 2TH|
|Principal Investigator:||Nicholas G Inston, FRCS||University Hospital Birmingham, UK.|