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Blood Pressure and Brain Blood Flow Regulation After Midodrine Administration in Those With Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01498809
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment
Orthostatic Intolerance Drug: Midodrine

Study Design
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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neural and Mechanical Baroreflex Sensitivity and Cerebral Blood Flow
Study Start Date : March 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

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Groups and Cohorts
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Intervention Details:
  • Drug: Midodrine
    Single 10 mg dose
    Other Name: Amatine, ProAmatine, Gutron

Outcome Measures
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Primary Outcome Measures :
  1. Baroreflex sensitivity [ Time Frame: Immediately after drug administration (30 mins) ]

Secondary Outcome Measures :
  1. Cerebral autoregulation [ Time Frame: Thirty minutes after administration ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01498809     History of Changes
Other Study ID Numbers: H11-02823
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014

Keywords provided by University of British Columbia:
Orthostatic intolerance in people with spinal cord injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Orthostatic Intolerance
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Primary Dysautonomias
Autonomic Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Midodrine
 Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action