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Treatment of Post-SCI Hypotension

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ClinicalTrials.gov Identifier: NCT02919917
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Autonomic Dysreflexia Orthostatic Hypotension Baroreceptor Integrity Sympathetic Integrity Vagal Integrity Hypotension Cerebral Blood Flow Blood Pressure Venous Occlusion Plethysmography Drug: Midodrine Hydrochloride Phase 2 Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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)
Masking Description: Therapists administering rehabilitation will be blinded to the randomization of patients enrolled in the study.
Primary Purpose: Treatment
Official Title: Treatment of Post-SCI Hypotension: A Randomized Controlled Study of Usual Care Versus Anti Hypotension Therapy
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Usual Care Group

Individuals randomized to the usual care group will receive BP management according to the usual care in current practice in the SCI Rehabilitation Unit.

Will receive treatment only if they experience symptoms that are associated with low BP (dizziness, lightheadedness, nausea, blurry vision, loss of consciousness, etc.).

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 .

Drug: Midodrine Hydrochloride
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 Name: Midodrine

Experimental: BP Threshold Treatment Group

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.

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.).

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.

Drug: Midodrine Hydrochloride
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 Name: Midodrine




Primary Outcome Measures :
  1. Rehabilitation [ Time Frame: Up to 5 years ]
    To compare time spent actively involved in rehabilitation program between two groups

  2. Systolic Blood Pressure [ Time Frame: Up to 5 years ]
    To compare time spent at a systolic BP > 140 mmHg; Compare time spent at a systolic BP < 110 mmHg for males and < 100 mmHg for females. This is based on twice-weekly 24-hour BP observations


Secondary Outcome Measures :
  1. Orthostatic Hypotension and Autonomic Dysreflexia [ Time Frame: Up to 5 years ]
    To compare groups on OH and AD symptoms by survey

  2. Cerebral Blood Flow [ Time Frame: Up to 5 years ]
    To compare seated middle cerebral artery blood flow velocity between the two groups



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919917


Contacts
Contact: Matthew T Maher, MS 718-584-9000 ext 1732 Matthew.maher@va.gov

Locations
United States, New York
VA Medical Center, Bronx Not yet recruiting
Bronx, New York, United States, 10468
Contact: Jill Wecht, EdD       jm.wecht@va.gov   
Contact: Nhuquynh Nguyen, BS    718-584-9000 ext 1732    Nhuquyhn.nguyen@va.gov   
Principal Investigator: Jill Wecht, EdD         
Sub-Investigator: William Bauman, MD         
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Andrew Delgado, MS         
Contact: Kristall Taylor, BS         
Principal Investigator: Thomas Bryce, MD         
Sub-Investigator: Miguel Escalon, MD         
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Jill M Wecht, Ed.D. James J. Peters VA Medical Center

Responsible Party: Jill M. Wecht, Ed.D., Principal Invesitgator, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02919917     History of Changes
Other Study ID Numbers: WEC-16-050
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hypotension, Orthostatic
Spinal Cord Injuries
Hypotension
Autonomic Dysreflexia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action