The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

Renal Failure Clinical Trial

Official title:

The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685710
• Other study ID #: RRK4178
• Status: Completed
• Phase: Phase 4
• First received: August 30, 2012
• Last updated: June 1, 2015
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University Hospital Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Renal Failure

Intervention

Drug:
• GTN patch

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

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital, Birmingham.	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Birmingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change to diameter of vein	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.	Initial assessment and 6 weeks after surgery	No
Secondary	Number of participants with adverse events	Those receiving the active patch will be compared with those receiving the placebo patch for adverse events	6 weeks	Yes