Clinical trial NCT02919917: Treatment of Post-SCI Hypotension
Official title: Treatment of Post-SCI Hypotension: A Randomized Controlled Study of Usual Care Versus Anti Hypotension Therapy
Conditions: Spinal Cord Injury
Autonomic Dysreflexia
Orthostatic Hypotension
Baroreceptor Integrity
Sympathetic Integrity
Vagal Integrity
Hypotension
Cerebral Blood Flow
Blood Pressure
Venous Occlusion Plethysmography
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.
Interventions:
description: Level 1: Compression stockings, abdominal binder Level 2: Midodrine 5mg 2x/d Level 3: Midodrine 10mg 2x/d Level 4: Midodrine 15mg 2x/d Level 5: Midodrine 20mg 2x/d Level 6 Midodrine 20mg 2x/d and Fludrocortisone 0.1mg 2x/d Level 7 Midodrine 20mg 2x/d and Fludrocortisone 0.2mg 2x/d
name: Midodrine Hydrochloride
other_name: Midodrine
type: Drug
description: Level 1: Compression stockings, abdominal binder Level 2: Midodrine 5mg 2x/d Level 3: Midodrine 10mg 2x/d Level 4: Midodrine 15mg 2x/d Level 5: Midodrine 20mg 2x/d Level 6 Midodrine 20mg 2x/d and Fludrocortisone 0.1mg 2x/d Level 7 Midodrine 20mg 2x/d and Fludrocortisone 0.2mg 2x/d
name: Midodrine Hydrochloride
other_name: Midodrine
type: Drug
Study arms:
design_group_description: Individuals randomized to the usual care group will receive BP management according to the usual care in current practice in the SCI Rehabilitation Unit.<br/>Will receive treatment only if they experience symptoms that are associated with low BP (dizziness, lightheadedness, nausea, blurry vision, loss of consciousness, etc.).<br/>Treatment to lessen or eliminate these symptoms of low blood pressure will be guided by the attending physician and can include physical countermeasures to increase blood pressure (abdominal binders, comperssion stockings, etc.) and/or midodrine .
design_group_title: Usual Care Group
design_group_type: Experimental
design_group_description: Individuals assigned to the BP threshold treatment group will receive BP management, regardless of symptoms, to maintain systolic BP between 111-135 mmHg for males and 101-135 mmHg for females for the duration of their in-patient hospital stay.<br/>This treatment will be started based on your low BP, regardless of if you experience symptoms that are associated with low BP (dizziness, lightheadedness, nausea, blurry vision, loss of consciousness, etc.). Before you start on any medication you will receive physical countermeasures to increase blood pressure (abdominal binders, comperssion stockings, etc.).<br/>If your blood pressure remains low after using these countermeasures you will begin to take midodrine 3 times a day as described in the intervention section. The dosage will increase and be stopped once until your seated SBP is between 111-135 mmHg.
design_group_title: BP Threshold Treatment Group
design_group_type: Experimental
Sponsor: James J. Peters Bronx Veterans Affairs Medical Center
Collaborators: Icahn School of Medicine at Mount Sinai
Drug name mappings:
name: 盐酸米多君
lang: CN
name: Midodrine Hydrochloride
lang: EN
name: ミドドリン塩酸塩
lang: JP