Hypotension
Conditions
Brief summary
The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.
Interventions
Determine best drug and dose to increase and stabilize SBP during orthostatic tilt
Sponsors
Kessler Foundation
James J. Peters Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* traumatic spinal cord injury * at least 12 months post injury * injury level of C1-T6 * AIS A, B or C * non-ambulatory * non-ventilator
Exclusion criteria
* Active psychiatric disorder * Stroke or cerebrovascular disease * Alzheimer's Disease or dementia * Unmanaged cardiac arrhythmias * Concurrent systemic, hepatic, or renal disease * Suspected or diagnosed malignancy * Neurological disease other than SCI * Self-reported history of three or more symptomatic episodes of AD per day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | 3 years | determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral blood flow velocity | 3 years | determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo |
| Symptoms of autonomic dysreflexia and orthostatic hypotension | 3 years | determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo |
Countries
United States
Contacts
Primary ContactMatt G. Maher, MS
Outcome results
None listed