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临床试验/NCT01685710
NCT01685710已完成4 期

The Use of Glyceryl Trinitrate Patches in Arteriovenous Fistulas

University Hospital Birmingham1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Change to diameter of vein

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary arteriovenous fistulas
  • Brachiocephalic
  • Radiocephalic (both proximal and distal)
  • >18 yrs old
  • Diabetics and smokers will be eligible for inclusion

排除标准

  • 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)
  • Medications
  • Sildenafil
  • Pre-existing nitrate use
  • Nitrate allergy
  • Closed-angle glaucoma
  • Chronically raised intra-cranial pressure
  • History of hypothyroid disease
  • < 18 years old

研究组 & 干预措施

Placebo patch

Placebo Comparator

Placebo patch, in situ for 24hrs

干预措施: placebo comparator (Drug)

GTN patch

Experimental

GTN patch 5mg, in situ 24hrs

干预措施: GTN patch (Drug)

结局指标

主要结局

Change to diameter of vein

时间窗: 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.

次要结局

  • Number of participants with adverse events(6 weeks)

研究者

发起方
University Hospital Birmingham
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mr Nick Inston

Consultant Surgeon

University Hospital Birmingham

研究点 (1)

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