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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Primary arteriovenous fistulas
>18 yrs old
Diabetics and smokers will be eligible for inclusion
Exclusion criteria
All complex vascular access procedures
Cardiovascular dysfunction
Marked anaemia (Hb<8)
Migraine
Medications
Nitrate allergy
Closed-angle glaucoma
Chronically raised intra-cranial pressure
History of hypothyroid disease
< 18 years old
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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