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

NCT01498809 | Completed DMC

• 1 other identifier: H11-02823
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthostatic Intolerance

Keywords

Orthostatic intolerance in people with spinal cord injury

Outcome Measures

Primary Outcomes (1)

• Baroreflex sensitivity

  Immediately after drug administration (30 mins)

Secondary Outcomes (1)

• Cerebral autoregulation

  Thirty minutes after administration

Interventions

Midodrine DRUG

Single 10 mg dose

Also known as: Amatine, ProAmatine, Gutron

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with spinal cord injury currently in primary care (less than one year post injury)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

GF Strong Hospital and Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

MeSH Terms

Conditions

Orthostatic Intolerance

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Darren Warburton, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Andrei Krassioukov, MD PhD

  GF Strong Hospital University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 23, 2011
• Study Start: March 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

CA (1)