Renal Failure Clinical Trial
Official title:
The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Elizabeth Hospital, Birmingham. | Birmingham | West Midlands |
Lead Sponsor | Collaborator |
---|---|
University Hospital Birmingham |
United Kingdom,
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
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 |
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