The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change to diameter of vein
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •Medications
- •Sildenafil
- •Pre-existing nitrate use
- •Nitrate allergy
- •Closed-angle glaucoma
- •Chronically raised intra-cranial pressure
- •History of hypothyroid disease
- •< 18 years old
Arms & Interventions
Placebo patch
Placebo patch, in situ for 24hrs
Intervention: placebo comparator (Drug)
GTN patch
GTN patch 5mg, in situ 24hrs
Intervention: GTN patch (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Number of participants with adverse events(6 weeks)
Investigators
Mr Nick Inston
Consultant Surgeon
University Hospital Birmingham