Orthostatic IntoleranceNCT01498809
Blood Pressure and Brain Blood Flow Regulation After Midodrine Administration in Those With Spinal Cord Injury
An observational study of Orthostatic Intolerance, run by University of British Columbia at 1 site in Canada.
Trial summary
This project aims to evaluate the physiological effects of Midodrine administration during orthostatic challenge in those with high level spinal cord injury. Midodrine has been shown to improve orthostatic symptoms in those with spinal cord injury but the physiological mechanisms influenced have not been identified. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Orthostatic Intolerance
- What is being tested?
- Midodrine
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals with spinal cord injury currently in primary care (less than one year post injury)
Who may be able to join
- To be included in the study, participants must have sustained a traumatic spinal cord injury within the ages of 18-49 years.
- Also, participants must have an injury level above the 6th thoracic vertebrae and be a non-smoker for a minimum of one year.
Who cannot join
- Any participants with a history of cardiovascular disease, pulmonary disease or diabetes mellitus will not be eligible.
- Also, participants will not be eligible to take part in study if they experiences acute distress, or are taking medications known to influence cardiovascular function.
- Patient will be not eligible for the study if he/she has known adverse reaction to Midodrine.
Trial locations and contacts
1 site in 1 country.
Canada1 site
GF Strong Hospital and Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
About this study
Official title: Neural and Mechanical Baroreflex Sensitivity and Cerebral Blood Flow
This project aims to evaluate the physiological effects of Midodrine administration during orthostatic challenge in those with high level spinal cord injury. Midodrine has been shown to improve orthostatic symptoms in those with spinal cord injury but the physiological mechanisms influenced have not been identified. The investigators will examine key physiological components influencing orthostatic tolerance. The investigators will do this, by measuring the baroreflex, and brain blood flow autoregulation (the ability to maintain brain blood flow) before during and after the sit-up test. Two sit-up tests will occur; one before Midodrine administration, and one after administration of a 10mg dose of Midodrine.
- Conditions
- Orthostatic Intolerance
- Being tested
- Midodrine
- Keywords
- Orthostatic intolerance in people with spinal cord injury
- Medical subject headings
- Orthostatic Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
Also called Amatine, ProAmatine, Gutron
Single 10 mg dose
What is being measured
The primary outcome is the main question the study is designed to answer.
Baroreflex sensitivity
Measured: Immediately after drug administration (30 mins)
Secondary outcomes (1)
Cerebral autoregulation
Measured: Thirty minutes after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic IntoleranceStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei Krassioukov, University of British Columbia
- Investigators
- Darren Warburton, PhD, Principal investigator, University of British ColumbiaAndrei Krassioukov, MD PhD, Principal investigator, GF Strong Hospital University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498809
- Sponsor's protocol ID
- H11-02823
- Status last verified
- Sep 2019
- First submitted
- 21 Dec 2011
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Mechanical Baroreflex Sensitivity and Cerebral Blood Flow
- ClinicalTrials.gov ID
- NCT01498809
- Acronym / sponsor ID
- H11-02823
- Conditions
- Orthostatic Intolerance
- Keywords
- Orthostatic intolerance in people with spinal cord injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to evaluate the physiological effects of Midodrine administration during orthostatic challenge in those with high level spinal cord injury. Midodrine has been shown to improve orthostatic symptoms in those with spinal cord injury but the physiological mechanisms influenced have not been identified. The investigators will examine key physiological components influencing orthostatic tolerance. The investigators will do this, by measuring the baroreflex, and brain blood flow autoregulation (the ability to maintain brain blood flow) before during and after the sit-up test. Two sit-up tests will occur; one before Midodrine administration, and one after administration of a 10mg dose of Midodrine.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals with spinal cord injury currently in primary care (less than one year post injury)
Key inclusion criteria (2 listed)
- To be included in the study, participants must have sustained a traumatic spinal cord injury within the ages of 18-49 years.
- Also, participants must have an injury level above the 6th thoracic vertebrae and be a non-smoker for a minimum of one year.
Key exclusion criteria (3 listed)
- Any participants with a history of cardiovascular disease, pulmonary disease or diabetes mellitus will not be eligible.
- Also, participants will not be eligible to take part in study if they experiences acute distress, or are taking medications known to influence cardiovascular function.
- Patient will be not eligible for the study if he/she has known adverse reaction to Midodrine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidodrineAlso: Amatine, ProAmatine, GutronSingle 10 mg dose | Drug | – |
Primary outcome
Baroreflex sensitivity
Time frame: Immediately after drug administration (30 mins)
1 secondary outcome
Cerebral autoregulation
Time frame: Thirty minutes after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Warburton, PhD principal investigator
University of British Columbia
Andrei Krassioukov, MD PhD principal investigator
GF Strong Hospital University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthostatic Intolerance, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baroreflex sensitivity (time frame: Immediately after drug administration (30 mins)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.