NCT01685710

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 2, 2015

Status Verified

June 1, 2015

Enrollment Period

2.1 years

First QC Date

August 30, 2012

Last Update Submit

June 1, 2015

Conditions

Renal Failure

Keywords

Arteriovenous fistulaPatencyGTN patch

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of participants with adverse events

    6 weeks

Study Arms (2)

GTN patch

EXPERIMENTAL

GTN patch 5mg, in situ 24hrs

Drug: GTN patch

Placebo patch

PLACEBO COMPARATOR

Placebo patch, in situ for 24hrs

Drug: placebo comparator

Interventions

GTN patchDRUG
Also known as: Minitran 5
GTN patch
placebo comparatorDRUG

This arm will be a placebo patch to the active drug patch to blind the trial.

Placebo patch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary arteriovenous fistulas
  • Brachiocephalic
  • Radiocephalic (both proximal and distal)
  • \>18 yrs old

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital, Birmingham.

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 18256379BACKGROUND

  • 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.

    PMID: 12205547BACKGROUND

  • 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.

    PMID: 27470183DERIVED

MeSH Terms

Conditions

Renal InsufficiencyArteriovenous Fistula

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Nicholas G Inston, FRCS

    University Hospital Birmingham, UK.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 14, 2012

Study Start

April 1, 2013

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

June 2, 2015

Record last verified: 2015-06

Locations

GB(1)