Treatment of Post-SCI Hypotension

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: James J. Peters Veterans Affairs Medical Center
• Collaborator: Icahn School of Medicine at Mount Sinai
• Treatments: Midodrine

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