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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01498809
First received: December 21, 2011
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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 Intervention
Orthostatic Intolerance
Drug: Midodrine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neural and Mechanical Baroreflex Sensitivity and Cerebral Blood Flow

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Baroreflex sensitivity [ Time Frame: Immediately after drug administration (30 mins) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cerebral autoregulation [ Time Frame: Thirty minutes after administration ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: March 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Midodrine
    Single 10 mg dose
    Other Name: Amatine, ProAmatine, Gutron
  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01498809     History of Changes
Other Study ID Numbers: H11-02823
Study First Received: December 21, 2011
Last Updated: March 14, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Orthostatic Intolerance
Mitral Valve Prolapse
Neurocirculatory Asthenia
Spinal Cord Injuries
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Heart Valve Prolapse
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Anxiety Disorders
Mental Disorders
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists

ClinicalTrials.gov processed this record on August 21, 2014