Treatment of Post-SCI Hypotension

Blood Pressure Clinical Trial

Official title:

Treatment of Post-SCI Hypotension: A Randomized Controlled Study of Usual Care Versus Anti Hypotension Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02919917
• Other study ID #: WEC-16-050
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 1, 2017
• Est. completion date: September 1, 2021

Study information

• Verified date: June 2023
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
United States	VA Medical Center, Bronx	Bronx	New York
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
James J. Peters Veterans Affairs Medical Center	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehabilitation	To compare time spent actively involved in rehabilitation program between two groups	Up to 5 years
Primary	Systolic Blood Pressure	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	Up to 5 years
Secondary	Orthostatic Hypotension and Autonomic Dysreflexia	To compare groups on OH and AD symptoms by survey	Up to 5 years
Secondary	Cerebral Blood Flow	To compare seated middle cerebral artery blood flow velocity between the two groups	Up to 5 years