NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI
NCT ID: NCT05635851
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
26 participants
INTERVENTIONAL
2025-09-30
2026-02-28
Brief Summary
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Detailed Description
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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.
Objectives: The investigators aim to evaluate whether GTN improves AD during normal at-home bowel care.
Research Design: The study is a randomised placebo-controlled double-blind crossover clinical trial to evaluate the effect of sublingual GTN (spray) on beat-to-beat cardiovascular responses to normal bowel care in 26 individuals with chronic high-level SCI who are known to have AD.
Statistical Analysis: Data will be analysed using R statistical software. Mean maximum blood pressure and mean drop in systolic blood pressure will be calculated. Mean time to onset of drug action will also be calculated. A paired t-test will be used to determine if there is a significant within-participant difference in the change of mean maximum blood pressure values or mean drop in systolic blood pressure between the placebo and the GTN conditions. Two-way repeated measures ANOVA will be used to compare symptoms, test conditions, and test phases. Categorical data will be analysed with Spearman's rank correlations and linear regressions to determine if any findings correlate with biological variables including level of injury, sex, and cardiovascular variables.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Glyceryl trinitrate sublingual spray
Glyceryl trinitrate (GTN) sublingual spray will be administered up to three times every fifteen minutes, each dose being 0.4mg.
Glyceryl Trinitrate Only Product in Oromucosal Dose Form
Glyceryl trinitrate will be administered via sublingual spray.
Placebo sublingual spray
An approximate flavour-matched placebo sublingual spray will be administered up to three times every fifteen minutes.
Placebo sublingual spray
A placebo sublingual spray will be administered.
Interventions
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Glyceryl Trinitrate Only Product in Oromucosal Dose Form
Glyceryl trinitrate will be administered via sublingual spray.
Placebo sublingual spray
A placebo sublingual spray will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* regular bowel care routine
* can communicate in English
Exclusion Criteria
* 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
19 Years
80 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
Simon Fraser University
OTHER
Responsible Party
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Dr. Victoria Claydon
Professor, Principal Investigator
Principal Investigators
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Victoria Claydon, PhD
Role: PRINCIPAL_INVESTIGATOR
Simon Fraser University
Central Contacts
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Other Identifiers
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H22-00878
Identifier Type: -
Identifier Source: org_study_id