The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas
GTN patch
+ placebo comparator
Congenital Abnormalities+16
+ Urogenital Diseases
+ Arteriovenous Malformations
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy 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