Blood Pressure and Brain Blood Flow Regulation After Midodrine Administration in Those With Spinal Cord Injury
This study is not yet open for participant recruitment.
Verified December 2011 by University of British Columbia
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: December 22, 2011
Last verified: December 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 21, 2011 | ||||||||
| Last Updated Date | December 22, 2011 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Baroreflex sensitivity [ Time Frame: Immediately after drug administration (30 mins) ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01498809 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Cerebral autoregulation [ Time Frame: Thirty minutes after administration ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Blood Pressure and Brain Blood Flow Regulation After Midodrine Administration in Those With Spinal Cord Injury | ||||||||
| Official Title ICMJE | Neural and Mechanical Baroreflex Sensitivity and Cerebral Blood Flow | ||||||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Individuals with spinal cord injury currently in primary care (less than one year post injury) |
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| Condition ICMJE | Orthostatic Intolerance | ||||||||
| Intervention ICMJE | Drug: Midodrine
Single 10 mg dose
Other Name: Amatine, ProAmatine, Gutron |
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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | February 2013 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 49 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01498809 | ||||||||
| Other Study ID Numbers ICMJE | H11-02823 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University of British Columbia | ||||||||
| Study Sponsor ICMJE | University of British Columbia | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||||||
| Verification Date | December 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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