Treatment of Post-SCI Hypotension
Condition: Spinal Cord Injury; Autonomic Dysreflexia; Orthostatic Hypotension; Baroreceptor Integrity; Sympathetic Integrity; Vagal Integrity; Hypotension; Cerebral Blood Flow; Blood Pressure; Venous Occlusion Plethysmography
MeSH terms: Spinal Cord Injuries; Hypotension, Orthostatic; Autonomic Dysreflexia; Hypotension
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      Baseline Testing: Subjects will visit the testing laboratory on the SCI Rehabilitation Unit
      for baseline data collection, prior to initiation of the treatment protocol. Upon arrival,
      subjects will be placed in the supine position on an adjustable surface for instrumentation,
      which will be conducted in a quiet, dimly lit, thermo-neutral testing environment. After a
      20-minute period of quiet rest, a 10-minute sample of supine heart rate (HR), respiratory
      rate, BP and CBF velocity data will be collected. Venous occlusion plethysmography (Vop) will
      be collected in the supine position for two 5-minute periods. After the supine data
      collection, subjects will be passively moved into the seated position, with the knees and
      hips at 90°, for the 10-minute seated data collection period. Subjects will be asked to
      complete two surveys related to AD and OH symptomology. Finally, subjects will be fitted with
      a 24-hour HR and BP monitor and will be asked to go about their normal routine. A record of
      all daily activities including rehabilitation, medications, eating and sleep/wake times will
      be logged. This testing session should take approximately 1 hour.

      Daily Testing: Every day supine and seated BP measurements will be performed at least three
      times per day. These BP assessments will be recorded in the supine and seated positions in
      the subject's room by a patient care associate who is blind to the study arm allocation. For
      every scheduled physical and occupational therapy session, the treating therapist will be
      asked to complete a brief 6 question survey to document if that session was altered,
      disrupted, or missed due to hypotension (Therapist Reported Version). The subject will also
      be asked to complete a brief survey to determine if from their perspective the session was
      altered, disrupted or missed due to hypotension (Subject Reported Version). In addition,
      every day a co-investigator and the attending physician for that subject will complete an EMR
      review of queried BP values within the previous 24 hours, symptoms of low BP, adverse events
      related to high or low BP, and will review (and act upon for the usual care arm) the protocol
      treatment decision tree.

      Weekly Testing: At weekly intervals of between 6 and 8 days, subjects will be asked to visit
      the testing laboratory on the SCI Rehabilitation Unit. Procedures for the weekly testing
      sessions will be the same as for the Baseline Testing. The 24-hour BP assessment will be
      conducted twice weekly.

      Discharge Testing: At discharge subjects will undergo similar testing as described during the
      Baseline and Weekly Testing with the addition of the Patient Global Impression of Change
      survey, which will be administered by the Mount Sinai Site Research Assistant.
    

Intervention name(s): Midodrine Hydrochloride; Midodrine Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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
Other intervention name(s): Midodrine; Midodrine
Intervention MeSH terms: Midodrine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Care Provider)
Primary purpose: Treatment