DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

Information source: University Hospital Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Failure

Intervention: GTN patch (Drug); placebo comparator (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital Birmingham

Official(s) and/or principal investigator(s):
Nicholas G Inston, FRCS, Principal Investigator, Affiliation: University Hospital Birmingham, UK.


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.

Clinical Details

Official title: The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change to diameter of vein

Secondary outcome: Number of participants with adverse events

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Queen Elizabeth Hospital, Birmingham., Birmingham, West Midlands B15 2TH, United Kingdom
Additional Information

Related publications:

Huijbregts HJ, Bots ML, Wittens CH, Schrama YC, Moll FL, Blankestijn PJ; CIMINO study group. Hemodialysis arteriovenous fistula patency revisited: results of a prospective, multicenter initiative. Clin J Am Soc Nephrol. 2008 May;3(3):714-9. doi: 10.2215/CJN.02950707. Epub 2008 Feb 6.

Akin EB, Topçu O, Ozcan H, Ersöz S, Aytaç S, Anadol E. Hemodynamic effect of transdermal glyceryl trinitrate on newly constructed arteriovenous fistula. World J Surg. 2002 Oct;26(10):1256-9. Epub 2002 Sep 4.

Starting date: April 2013
Last updated: June 1, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017