Treatment of Post-SCI Hypotension

NCT02919917 | Completed Phase 2 Results FDA Drug

• 1 other identifier: WEC-16-050
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injury; Autonomic Dysreflexia; Orthostatic Hypotension; Baroreceptor Integrity; Sympathetic Integrity; Vagal Integrity; Hypotension; Cerebral Blood Flow; Blood Pressure; Venous Occlusion Plethysmography

Outcome Measures

Primary Outcomes (2)

• Affected Therapy Sessions

  Responses to the questions "was the therapy session affected by low BP or concern for low BP development?" between the usual care and BP threshold treatment groups. The percent of sessions with a "yes" response are reported.

  Inpatient hospitalization (up to 4 months)

• Systolic Blood Pressure

  Systolic hypertension (\>/= 140 mmHg)

  Inpatient hospitalization (up to 4 months)

Secondary Outcomes (2)

• Systolic Blood Pressure

  Inpatient Hospitalizations (up to 4 months)

• Missed Therapy Sessions

  Inpatient Hospitalizations (up to 4 months)

Study Arms (2)

Usual Care Group

EXPERIMENTAL

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

BP Threshold Treatment Group

EXPERIMENTAL

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

Interventions

Midodrine Hydrochloride DRUG

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

Also known as: Midodrine

BP Threshold Treatment Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (2)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Related Publications (2)

• Wecht JM, Weir JP, Huang V, Escalon MX, Bryce TN. Treatment of Orthostatic Hypotension During Acute Inpatient Rehabilitation After Spinal Cord Injury: Usual Care vs. Anti-hypotensive Therapy. Am J Hypertens. 2024 Jul 15;37(8):554-560. doi: 10.1093/ajh/hpae057.

  PMID: 38712567 DERIVED

• Vaccaro DH, Weir JP, Noonavath M, Bryce TN, Escalon MX, Huang V, Delgado A, Wecht JM. Orthostatic systemic and cerebral hemodynamics in newly injured patients with spinal cord injury. Auton Neurosci. 2022 Jul;240:102973. doi: 10.1016/j.autneu.2022.102973. Epub 2022 Mar 18.

  PMID: 35366432 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Autonomic Dysreflexia; Hypotension, Orthostatic; Hypotension

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Autonomic Nervous System Diseases; Orthostatic Intolerance; Primary Dysautonomias; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Dr. Jill Wecht
• Organization: Icahn School of Medicine at Mount Sinai

jm.wecht@va.gov

718-584-9000

Study Officials

• Jill M Wecht, Ed.D.

  James J. Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Therapists administering rehabilitation will be blinded to the randomization of patients enrolled in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invesitgator

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 30, 2016
• Study Start: June 1, 2017
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)