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Clinical Trials/NCT01498809
NCT01498809CompletedNot Applicable

Neural and Mechanical Baroreflex Sensitivity and Cerebral Blood Flow

University of British Columbia1 site in 1 country22 target enrollmentStarted: March 2012Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Baroreflex sensitivity

Study Overview

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 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

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 49 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Baroreflex sensitivity

Time Frame: Immediately after drug administration (30 mins)

Secondary Outcomes

  • Cerebral autoregulation(Thirty minutes after administration)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrei Krassioukov

Principal Investigator

University of British Columbia

Study Sites (1)

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