Completed

The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

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What is being tested

GTN patch

+ placebo comparator

Drug
Who is being recruted

Congenital Abnormalities+16

+ Urogenital Diseases

+ Arteriovenous Malformations

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity Hospital Birmingham
Last updated: June 2, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity Hospital Birmingham
Last updated: June 2, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesUrogenital DiseasesArteriovenous MalformationsCardiovascular DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsFistulaKidney DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathological Conditions, Signs and SymptomsUrologic DiseasesVascular DiseasesVascular FistulaCardiovascular AbnormalitiesPathological Conditions, AnatomicalFemale Urogenital DiseasesMale Urogenital DiseasesVascular MalformationsArteriovenous FistulaRenal Insufficiency

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
GTN patch 5mg, in situ 24hrs

Group II

Placebo
Placebo patch, in situ for 24hrs

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Queen Elizabeth Hospital, Birmingham.

Birmingham, United KingdomOpen Queen Elizabeth Hospital, Birmingham. in Google Maps
CompletedOne Study Center