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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

December 21, 2011
March 14, 2014
March 2012
November 2013   (final data collection date for primary outcome measure)
Baroreflex sensitivity [ Time Frame: Immediately after drug administration (30 mins) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01498809 on ClinicalTrials.gov Archive Site
Cerebral autoregulation [ Time Frame: Thirty minutes after administration ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Blood Pressure and Brain Blood Flow Regulation After Midodrine Administration in Those With Spinal Cord Injury
Neural and Mechanical Baroreflex Sensitivity and Cerebral Blood Flow

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Orthostatic Intolerance
Drug: Midodrine
Single 10 mg dose
Other Name: Amatine, ProAmatine, Gutron
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01498809
H11-02823
Yes
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Darren Warburton, PhD University of British Columbia
Principal Investigator: Andrei Krassioukov, MD PhD GF Strong Hospital University of British Columbia
University of British Columbia
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP