Treatment of Post-SCI Hypotension

Recruiting at1 trial location

Overseen by Jill M Wecht, Ed.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: James J. Peters Veterans Affairs Medical Center

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jill M Wecht, Ed.D.

Principal Investigator

James J. Peters VA Medical Center

Eligibility Criteria

Inclusion Criteria

Any level of injury;

Any AIS grade of SCI;

Non-ventilator dependent

Treatment Details

Interventions

• Midodrine Hydrochloride (Alpha-1 Agonist)

Participant Groups

Group I: Usual Care Group Experimental Treatment 1 Intervention

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 .

Group II: BP Threshold Treatment Group Experimental Treatment 1 Intervention

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.

Midodrine Hydrochloride is already approved in Canada for the following indications:

Approved in Canada as Midodrine Hydrochloride for:

• Orthostatic hypotension

Who Is Running the Clinical Trial?

James J. Peters Veterans Affairs Medical Center

Lead Sponsor

Trials

59

Recruited

2,900+

Dr. Balavankatesh Kanna

James J. Peters Veterans Affairs Medical Center

Chief Executive Officer since 2022

MD from Coimbatore Medical College, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Meenakshi Zaidi

James J. Peters Veterans Affairs Medical Center

Chief Medical Officer since 2017

MD, Fellow of the American College of Physicians

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA