NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 26
- 主要终点
- Blood pressure change during bowel care
研究概览
简要总结
This project aims to evaluate the safety and efficacy of using a short-acting drug to reduce the maximal blood pressure during dangerous blood pressure spikes that happen during bowel care in individuals with spinal cord injury. the investigators will monitor the physiological effects of this drug during at-home bowel care to best understand the drug's effects in typical use.
详细描述
Purpose: The primary purpose of this study is to investigate the effects of sublingual nitric oxide (NO) donor spray on cardiovascular changes triggered by bowel care.
Hypothesis: NO donor spray will lower the maximum blood pressure spikes during high blood pressure events triggered by bowel care in people with spinal cord injury.
Justification: In people with spinal cord injury, episodes of high blood pressure are common during strong sensory stimuli such as those present during routine bowel care. These episodes of high blood pressure can be dangerous due to the magnitude of blood pressure increase and because they can be accompanied by irregular heart beats. This condition, known as autonomic dysreflexia (AD), is most common in individuals with high-level injuries.
The experience of autonomic dysreflexia can vary widely between individuals: some have goosebumps, sweating, facial flushing or headaches, while others have no symptoms at all, despite their changes in heart rate and blood pressure.
One possible approach to help manage AD is the use of fast-acting, short-term vasodilators such as nitric oxide (NO) donors (e.g. glyceryl trinitrate, GTN) to decrease blood pressure during AD experienced during bowel care. This approach is already part of the clinical recommendations for management of AD during bowel care, and yet its safety and efficacy have never been tested during at-home bowel care. Currently, a sublingual GTN spray is not often used in the home setting, although it is thought that using this medication might reduce the cardiovascular effects of bowel care after spinal cord injury. The long-term consequences of these short-term elevations in blood pressure during autonomic dysreflexia are not fully understood, but given that they are often associated with discomfort, and have been known to be associated with more severe events such as stroke, it would be beneficial to reduce their occurrence during daily care routines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants must have had a traumatic spinal cord injury at least one year ago
- •regular bowel care routine
- •can communicate in English
排除标准
- •cauda equina or conus lesions
- •currently use ventilator
- •colostomy, or do not perform regular bowel care
- •skin breakdown (pressure sores)
- •cannot communicate in English
- •under 19 years old
- •possibly or certainly pregnant
- •medical/psychiatric condition or substance abuse that is likely to affect ability to complete study
- •currently using medications containing PDE-5 inhibitors
- •currently using medications containing GTN
- •allergy to GTN
研究组 & 干预措施
Glyceryl trinitrate sublingual spray
Glyceryl trinitrate (GTN) sublingual spray will be administered up to three times every fifteen minutes, each dose being 0.4mg.
干预措施: Glyceryl Trinitrate Only Product in Oromucosal Dose Form (Drug)
Placebo sublingual spray
An approximate flavour-matched placebo sublingual spray will be administered up to three times every fifteen minutes.
干预措施: Placebo sublingual spray (Other)
结局指标
主要结局
Blood pressure change during bowel care
时间窗: Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
Beat-to-beat blood pressure will be recorded using a finger blood pressure cuff (Finometer) on two occasions within 28 days, for up to one hour on each occasion.
次要结局
- Change in symptoms of autonomic dysreflexia(Time Frame: Measured upon completion of bowel care (approximately one hour) on two occasions within 28 days.)
- Incidence of arrhythmia(Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.)
研究者
Dr. Victoria Claydon
Professor, Principal Investigator
Simon Fraser University