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

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

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT01498809 History of Changes
Other Study ID Numbers:	H11-02823
First Posted:	December 23, 2011
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