Renal FailurePhase 4NCT01685710
The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas
A Phase 4 study testing GTN patch in people with Renal Failure, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- GTN patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary arteriovenous fistulas
- Brachiocephalic
- Radiocephalic (both proximal and distal)
- >18 yrs old
- Diabetics and smokers will be eligible for inclusion
Who cannot join
- All complex vascular access procedures
- Re-do brachiocephalic and radiocephalic fistulas
- Brachiobasilic fistulas
- Prosthetic grafts
- Cardiovascular dysfunction
- Hypotension (systolic <90)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth Hospital, Birmingham.
Birmingham, West Midlands, B15 2TH
About this study
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.
Read the 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.
- Conditions
- Renal Failure
- Being tested
- GTN patch, placebo comparator
- Keywords
- Arteriovenous fistula, Patency, GTN patch
- Medical subject headings
- Renal Insufficiency, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTN patchDrug
Also called Minitran 5
placebo comparatorDrug
This arm will be a placebo patch to the active drug patch to blind the trial.
| Study group | Role | What they receive |
|---|---|---|
| GTN patch | Experimental | GTN patch 5mg, in situ 24hrs Receives: Drug: GTN patch |
| Placebo patch | Placebo comparator | Placebo patch, in situ for 24hrs Receives: Drug: placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initial assessment and 6 weeks after surgery
Secondary outcomes (1)
Number of participants with adverse events
Those receiving the active patch will be compared with those receiving the placebo patch for adverse events
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr Nick Inston, University Hospital Birmingham
- Investigators
- Nicholas G Inston, FRCS, Principal investigator, University Hospital Birmingham, UK.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685710
- Sponsor's protocol ID
- RRK4178
- Status last verified
- Jun 2015
- First submitted
- 30 Aug 2012
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18256379Akin 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.
PubMed 12205547Field 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.
PubMed 27470183
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas
- ClinicalTrials.gov ID
- NCT01685710
- Acronym / sponsor ID
- RRK4178
- Conditions
- Renal Failure
- Keywords
- Arteriovenous fistula, Patency, GTN patch
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GTN patch | Experimental | Drug: GTN patchGTN patch 5mg, in situ 24hrs |
| Placebo patch | Placebo comparator | Drug: placebo comparatorPlacebo patch, in situ for 24hrs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary arteriovenous fistulas
- >18 yrs old
- Diabetics and smokers will be eligible for inclusion
Key exclusion criteria (19 listed)
- All complex vascular access procedures
- Cardiovascular dysfunction
- Marked anaemia (Hb<8)
- Migraine
- Medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTN patchAlso: Minitran 5 | Drug | GTN patch |
| placebo comparatorThis arm will be a placebo patch to the active drug patch to blind the trial. | Drug | Placebo patch |
Primary outcome
Change to diameter of vein
Time frame: Initial assessment and 6 weeks after surgery
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.
1 secondary outcome
Number of participants with adverse events
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Background: PubMed 18256379Huijbregts 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.
- Background: PubMed 12205547Akin 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.
- Derived from this study: PubMed 27470183Field 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas G Inston, FRCS principal investigator
University Hospital Birmingham, UK.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GTN patch in people with Renal Failure, run by University Hospital Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change to diameter of vein (time frame: Initial assessment and 6 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01685710, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.