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

NCT ID: NCT01498809

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Orthostatic Intolerance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Midodrine

Single 10 mg dose

Intervention Type DRUG

Other Intervention Names

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Amatine, ProAmatine, Gutron

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Andrei Krassioukov

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Darren Warburton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Andrei Krassioukov, MD PhD

Role: PRINCIPAL_INVESTIGATOR

GF Strong Hospital University of British Columbia

Locations

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GF Strong Hospital and Rehabilitation Centre

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H11-02823

Identifier Type: -

Identifier Source: org_study_id

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