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The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

Primary Purpose

Renal Failure

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
GTN patch
placebo comparator
Sponsored by
University Hospital Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure focused on measuring Arteriovenous fistula, Patency, GTN patch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Elizabeth Hospital, Birmingham.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GTN patch

Placebo patch

Arm Description

GTN patch 5mg, in situ 24hrs

Placebo patch, in situ for 24hrs

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of participants with adverse events
Those receiving the active patch will be compared with those receiving the placebo patch for adverse events

Full Information

First Posted
August 30, 2012
Last Updated
June 1, 2015
Sponsor
University Hospital Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT01685710
Brief Title
The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas
Official Title
The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
Arteriovenous fistula, Patency, GTN patch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GTN patch
Arm Type
Experimental
Arm Description
GTN patch 5mg, in situ 24hrs
Arm Title
Placebo patch
Arm Type
Placebo Comparator
Arm Description
Placebo patch, in situ for 24hrs
Intervention Type
Drug
Intervention Name(s)
GTN patch
Other Intervention Name(s)
Minitran 5
Intervention Type
Drug
Intervention Name(s)
placebo comparator
Intervention Description
This arm will be a placebo patch to the active drug patch to blind the trial.
Primary Outcome Measure Information:
Title
Change to diameter of vein
Description
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.
Time Frame
Initial assessment and 6 weeks after surgery
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Those receiving the active patch will be compared with those receiving the placebo patch for adverse events
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas G Inston, FRCS
Organizational Affiliation
University Hospital Birmingham, UK.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Hospital, Birmingham.
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18256379
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.
Results Reference
background
PubMed Identifier
12205547
Citation
Akin EB, Topcu O, Ozcan H, Ersoz S, Aytac S, Anadol E. Hemodynamic effect of transdermal glyceryl trinitrate on newly constructed arteriovenous fistula. World J Surg. 2002 Oct;26(10):1256-9. doi: 10.1007/s00268-002-6515-1. Epub 2002 Sep 4.
Results Reference
background
PubMed Identifier
27470183
Citation
Field M, McGrogan D, Marie Y, Joinson M, Andujar C, Dutton M, Krishnan H, Hodson J, van Dellen D, Inston NG. Randomized clinical trial of the use of glyceryl trinitrate patches to aid arteriovenous fistula maturation. Br J Surg. 2016 Sep;103(10):1269-75. doi: 10.1002/bjs.10217. Epub 2016 Jul 29.
Results Reference
derived

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The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

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