Blood Pressure and Brain Blood Flow Regulation After Midodrine Administration in Those With Spinal Cord Injury
This study has been completed.
Sponsor:
University of British Columbia
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01498809
First received: December 21, 2011
Last updated: March 14, 2014
Last verified: March 2014
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Purpose
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 investiagtors will examine key physiological components influencing orthostatic tolerance. The investiagtors 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.
| Condition | Intervention |
|---|---|
|
Orthostatic Intolerance |
Drug: Midodrine |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Neural and Mechanical Baroreflex Sensitivity and Cerebral Blood Flow |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- Baroreflex sensitivity [ Time Frame: Immediately after drug administration (30 mins) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Cerebral autoregulation [ Time Frame: Thirty minutes after administration ] [ Designated as safety issue: Yes ]
| Enrollment: | 22 |
| Study Start Date: | March 2012 |
| Study Completion Date: | November 2013 |
| Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Midodrine
Single 10 mg dose
Other Name: Amatine, ProAmatine, Gutron
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Individuals with spinal cord injury currently in primary care (less than one year post injury)
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498809
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498809
Locations
| Canada, British Columbia | |
| GF Strong Hospital and Rehabilitation Centre | |
| Vancouver, British Columbia, Canada, V5Z 2G9 | |
Sponsors and Collaborators
University of British Columbia
Investigators
| Principal Investigator: | Darren Warburton, PhD | University of British Columbia | |
| Principal Investigator: | Andrei Krassioukov, MD PhD | GF Strong Hospital University of British Columbia |
More Information
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01498809 History of Changes |
| Other Study ID Numbers: | H11-02823 |
| Study First Received: | December 21, 2011 |
| Last Updated: | March 14, 2014 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Orthostatic intolerance in people with spinal cord injury |
Additional relevant MeSH terms:
|
Mitral Valve Prolapse Neurocirculatory Asthenia Orthostatic Intolerance Anxiety Disorders Autonomic Nervous System Diseases Cardiovascular Diseases Heart Diseases |
Heart Valve Diseases Heart Valve Prolapse Mental Disorders Nervous System Diseases Neurologic Manifestations Primary Dysautonomias Signs and Symptoms |
ClinicalTrials.gov processed this record on February 27, 2015