Phase 3
N=66
Treatment of Post-SCI Hypotension
Spinal Cord Injury · Autonomic Dysreflexia · Orthostatic Hypotension · Baroreceptor Integrity · Sympathetic Integrity
Bottom Line
View on ClinicalTrials.gov: NCT02919917 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Affected Therapy Sessions — 16.4; 10.9 percentage of sessions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Midodrine Hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- James J. Peters Veterans Affairs Medical Center
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Affected Therapy Sessions |
16.4; 10.9 | — |
| PRIMARY Systolic Blood Pressure |
39.7; 43.0 | — |
| SECONDARY Systolic Blood Pressure |
39.7; 43.0 | — |
| SECONDARY Missed Therapy Sessions |
58.60; 65.8 | — |
Summary
While treatment strategies for OH have been identified for use in persons with acute SCI, the field of SCI medicine lacks a gold standard for treatment thresholds and well-defined outcome parameters. Comprehensively documenting the impact of orthostatic hypotension (OH), regardless of symptoms, during acute rehabilitation and identifying the effects of two different treatment approaches on therapy participation and adherence to an intended rehabilitation plan could have a significant impact on clinical practice in the acute rehabilitation setting following SCI.
Eligibility Criteria
Inclusion Criteria
- Any level of injury;
- Any AIS grade of SCI;
- Non-ventilator dependent
- Primarily wheelchair dependent for mobility;
- Duration of injury < 1 year
- Systolic BP less than 110 mmHg and/or diastolic BP less than 70 mmHg for males.
- Systolic BP less than 100 mmHg and/or diastolic BP less than 70 mmHg for females
- Primary Language is English.
- Able to provide informed consent
Exclusion Criteria
- Have insufficient mental capacity to independently provide informed consent
- Have insufficient English speaking or reading ability to provide informed consent or complete assessments in English
- Have contraindications to the use of midodrine hydrochloride
- Are pregnant
Data sourced from ClinicalTrials.gov (NCT02919917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.