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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-80
SponsorSimon Fraser University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

participants must have had a traumatic spinal cord injury at least one year ago

regular bowel care routine

can communicate in English

Disqualifiers

cauda equina or conus lesions

currently use ventilator

colostomy, or do not perform regular bowel care

skin breakdown (pressure sores)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Glyceryl Trinitrate Only Product in Oromucosal Dose Form

    Drug

    Glyceryl trinitrate will be administered via sublingual spray.

  • Placebo sublingual spray

    Other intervention

    A placebo sublingual spray will be administered.

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Glyceryl trinitrate sublingual sprayExperimental treatment 1 intervention
Group B: Placebo sublingual sprayPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.

Secondary outcomes

1

Change in symptoms of autonomic dysreflexia

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.
2

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.

Time frame
Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Simon Fraser University

Lead sponsor

University of British Columbia

Collaborator

This trial is not recruiting at the moment. You can still explore other options: