Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GTN patch | Experimental | GTN patch 5mg, in situ 24hrs |
|
| Placebo patch | Placebo Comparator | Placebo patch, in situ for 24hrs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTN patch | Drug |
|
| |
| placebo comparator |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Primary arteriovenous fistulas
>18 yrs old
Diabetics and smokers will be eligible for inclusion
Exclusion Criteria:
All complex vascular access procedures
Cardiovascular dysfunction
Marked anaemia (Hb<8)
Migraine
Medications
Nitrate allergy
Closed-angle glaucoma
Chronically raised intra-cranial pressure
History of hypothyroid disease
< 18 years old
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicholas G Inston, FRCS | University Hospital Birmingham, UK. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital, Birmingham. | Birmingham | West Midlands | B15 2TH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18256379 | Background | 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. | |
| 12205547 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
This arm will be a placebo patch to the active drug patch to blind the trial. |
|
| 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. |
| 27470183 | Derived | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |