The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GTN patch

GTN patch 5mg, in situ 24hrs

Group Type EXPERIMENTAL

GTN patch

Intervention Type DRUG

Placebo patch

Placebo patch, in situ for 24hrs

Group Type PLACEBO_COMPARATOR

placebo comparator

Intervention Type DRUG

This arm will be a placebo patch to the active drug patch to blind the trial.

Interventions

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GTN patch

Intervention Type DRUG

placebo comparator

This arm will be a placebo patch to the active drug patch to blind the trial.

Intervention Type DRUG

Other Intervention Names

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Minitran 5

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No