Effects of Exercise and Improved Nitric Oxide Bioavailability on Arteriovenous Fistula Maturation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Count of Participants With Mature Arteriovenous Fistula (AVF)
研究概览
简要总结
This project will examine if enhancing Nitric Oxide (NO) bioavailability increases the rates of arteriovenous fistula (AVF) maturation in end stage renal disease patients requiring vascular access for hemodialysis. To enhance NO bioavailability the study team will utilize a program of forearm exercise training, application of nitroglycerin ointment or both. Goals of this study are (A) to measure if recruited subjects can tolerate the intervention protocols, and determine if dependent variable measures, including surgery outcome, and measurement of physiologic and biologic markers, can be obtained; (B) To measure subject compliance and adherence rates for each of the intervention arms and testing visits; (C) To examine which intervention or combination of interventions demonstrates the strongest preliminary effects in order to estimate power for a pivotal intent to treat trial; and (D) explore group differences in clinical vascular markers and biologic markers in vein tissue.
详细描述
This project will examine if enhancing Nitric Oxide (NO) bioavailability increases the rates of arteriovenous fistula (AVF) maturation in end stage renal disease patients requiring vascular access for hemodialysis. To enhance NO bioavailability the study team will utilize a program of forearm exercise training, application of nitroglycerin ointment or both.
Following entry into the study, approximately 4 weeks prior to surgery subjects will undergo a series of non-invasive tests of vascular function in the arm of fistula creation. Following this vascular function testing, subjects will follow the intervention treatment for 4 weeks. After 4 weeks of intervention treatment and prior to surgery, the vascular function analysis will be repeated to determine if the interventions had an effect on arm vascular function. Surgery to create the AVF will follow the second vascular function analysis. A discard sample of the vein used to create the AVF and a blood sample will be collected during surgery to assess potential biologic differences between intervention groups. The interventions will be continued until 4 weeks following surgery. Subjects will be followed to determine if the AVF matured and was successfully used for dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Life expectancy of at least 6 months
- •Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
- •Ability to understand and comply with the requirements of the entire study and communicate with the study team.
- •Written informed consent using a document that has been approved by the Duke Human Institutional Review Board.
- •If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative pregnancy test and be willing to use contraception until completion of 8 weeks of intervention. This will include abstinence, barrier methods, hormones, or intra-uterine device.
排除标准
- •Patients currently on medication that is contraindicated with nitropaste, including isosorbide nitrate therapy, nitroglycerin, minoxidil, or PDE inhibitors (i.e. Sildenafil).
- •Patients with a diastolic blood pressure below 65 or a systolic blood pressure below
- •Patients with a history of illicit drug use in the previous 5 years.
- •Patients who would require AVF placement before completion of the initial 4 weeks of intervention therapy
- •Patients who are otherwise are not suitable for 8 weeks of handgrip training or nitropaste therapy.
- •Patients under the 18 of age are not eligible for nitropaste interventions
研究组 & 干预措施
Handgrip training group
Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes
干预措施: Handgrip training (Other)
Nitroglycerin ointment group
Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
干预措施: Nitroglycerin ointment (Drug)
Combined handgrip training /Nitroglycerin ointment group
Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
干预措施: Handgrip training (Other)
Combined handgrip training /Nitroglycerin ointment group
Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
干预措施: Nitroglycerin ointment (Drug)
结局指标
主要结局
Count of Participants With Mature Arteriovenous Fistula (AVF)
时间窗: 3 month post surgery to create AVF
Use of AVF for dialysis for dialysis dependent participants, or fistula deemed mature based on physical exam in predialysis participants (diameter \>6 mm, blood flow \>600 ml by ultrasound or estimated by physical exam).
次要结局
- Count of Participants Using Their AVF for Dialysis(12 months post surgery)
- Count of Participants With a Patent Fistula(3 months post surgery)