search
Back to results

NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI (NO AD)

Primary Purpose

Spinal Cord Injuries, Autonomic Dysreflexia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Glyceryl Trinitrate Only Product in Oromucosal Dose Form
Placebo sublingual spray
Sponsored by
Simon Fraser University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring spinal cord injury, autonomic dysreflexia, blood pressure, bowel care management, defecation

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: participants must have had a traumatic spinal cord injury at least one year ago regular bowel care routine can communicate in English Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Glyceryl trinitrate sublingual spray

    Placebo sublingual spray

    Arm Description

    Glyceryl trinitrate (GTN) sublingual spray will be administered up to three times every fifteen minutes, each dose being 0.4mg.

    An approximate flavour-matched placebo sublingual spray will be administered up to three times every fifteen minutes.

    Outcomes

    Primary Outcome Measures

    Blood pressure change during bowel care
    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.

    Secondary Outcome Measures

    Change in symptoms of autonomic dysreflexia
    Symptoms will be recorded after each arm of testing to determine if the drug condition improves symptoms
    Incidence of arrhythmia
    Beat-to-beat ECG will be recorded using a Finometer on two occasions within 28 days, for up to one hour on each occasion.

    Full Information

    First Posted
    October 4, 2022
    Last Updated
    April 17, 2023
    Sponsor
    Simon Fraser University
    Collaborators
    University of British Columbia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05635851
    Brief Title
    NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI
    Acronym
    NO AD
    Official Title
    NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    February 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Simon Fraser University
    Collaborators
    University of British Columbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries, Autonomic Dysreflexia
    Keywords
    spinal cord injury, autonomic dysreflexia, blood pressure, bowel care management, defecation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    26 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Glyceryl trinitrate sublingual spray
    Arm Type
    Experimental
    Arm Description
    Glyceryl trinitrate (GTN) sublingual spray will be administered up to three times every fifteen minutes, each dose being 0.4mg.
    Arm Title
    Placebo sublingual spray
    Arm Type
    Placebo Comparator
    Arm Description
    An approximate flavour-matched placebo sublingual spray will be administered up to three times every fifteen minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    Glyceryl Trinitrate Only Product in Oromucosal Dose Form
    Other Intervention Name(s)
    GTN
    Intervention Description
    Glyceryl trinitrate will be administered via sublingual spray.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo sublingual spray
    Other Intervention Name(s)
    Placebo spray
    Intervention Description
    A placebo sublingual spray will be administered.
    Primary Outcome Measure Information:
    Title
    Blood pressure change during bowel care
    Description
    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.
    Time Frame
    Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
    Secondary Outcome Measure Information:
    Title
    Change in symptoms of autonomic dysreflexia
    Description
    Symptoms will be recorded after each arm of testing to determine if the drug condition improves symptoms
    Time Frame
    Time Frame: Measured upon completion of bowel care (approximately one hour) on two occasions within 28 days.
    Title
    Incidence of arrhythmia
    Description
    Beat-to-beat ECG will be recorded using a Finometer on two occasions within 28 days, for up to one hour on each occasion.
    Time Frame
    Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: participants must have had a traumatic spinal cord injury at least one year ago regular bowel care routine can communicate in English Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Victoria Claydon, Dr.
    Phone
    778-782-8513
    Email
    victoria_claydon@sfu.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Victoria Claydon, PhD
    Organizational Affiliation
    Simon Fraser University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI

    We'll reach out to this number within 24 hrs