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

Orthostatic Intolerance Clinical Trial

Official title:

Neural and Mechanical Baroreflex Sensitivity and Cerebral Blood Flow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498809
• Other study ID #: H11-02823
• Status: Completed
• Start date: March 2012
• Est. completion date: November 2013

Study information

• Verified date: September 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Orthostatic Intolerance
• Spinal Cord Injuries

Intervention

Drug:
• Midodrine
Single 10 mg dose

Locations

Country	Name	City	State
Canada	GF Strong Hospital and Rehabilitation Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baroreflex sensitivity		Immediately after drug administration (30 mins)
Secondary	Cerebral autoregulation		Thirty minutes after administration