Treatment of Post-SCI Hypotension: A Randomized Controlled Study of Usual Care Versus Anti Hypotension Therapy

WEC-16-050

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.

2017-06-01

2021-09-01

2021-09-01

Completed

Early phase I

66

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Newly injured individuals with SCI will be eligible to participate if they demonstrate hypotension (systolic blood pressure \\</= 110 mmHg in males or \\</= 100 mmHg in females) upon admission to acute in-patient rehabilitation at Mount Sinai Medical Center, New York, NY. Eligible participants will be randomized to usual care (administered anti-hypotensive therapy only if they demonstrate symptoms of hypotension: dizziness, lightheadedness, nausea, blurred vision, syncope) or treatment of hypotension based on a systolic blood pressure below the hypotensive threshold. Time spent in active rehabilitation program will be compared between the usual care and treatment groups.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Therapists administering rehabilitation will be blinded to the randomization of patients enrolled in the study.', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}

2023-06-26