CompletedPhase 2/3

Treatment of Post-SCI Hypotension

United States66 participantsStarted 2017-06-01

Plain-language 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.

Who can participate

Age range18 Years – 89 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Affected Therapy Sessions

Timeframe: Inpatient hospitalization (up to 4 months)

Systolic Blood Pressure

Timeframe: Inpatient hospitalization (up to 4 months)

Trial details

NCT IDNCT02919917

SponsorJames J. Peters Veterans Affairs Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2021-09-01

Results submitted2023-07-18