Spinal Cord InjuryPhase 2/3NCT02919917
Treatment of Post-SCI Hypotension
A Phase 2/3 study testing Midodrine Hydrochloride in people with Spinal Cord Injury and Autonomic Dysreflexia, run by James J. Peters Veterans Affairs Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Autonomic Dysreflexia, Orthostatic Hypotension
- What is being tested?
- Midodrine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2017to 1 Sep 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai School of Medicine
New York, New York, 10029
VA Medical Center, Bronx
The Bronx, New York, 10468
About this study
Official title: Treatment of Post-SCI Hypotension: A Randomized Controlled Study of Usual Care Versus Anti Hypotension Therapy
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.
Read the 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.
- Conditions
- Spinal Cord Injury, Autonomic Dysreflexia, Orthostatic Hypotension, Baroreceptor Integrity, Sympathetic Integrity, Vagal Integrity
- Being tested
- Midodrine Hydrochloride
- Medical subject headings
- Spinal Cord Injuries, Autonomic Dysreflexia, Hypotension, Orthostatic, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midodrine HydrochlorideDrug
Also called Midodrine
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 HydrochlorideDrug
Also called Midodrine
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
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: Drug: Midodrine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Inpatient hospitalization (up to 4 months)
Systolic Blood Pressure
Systolic hypertension (>/= 140 mmHg)
Measured: Inpatient hospitalization (up to 4 months)
Secondary outcomes (2)
Systolic Blood Pressure
Systolic hypotension (males: < 110 mmHg; females: < 100 mmHg)
Measured: Inpatient Hospitalizations (up to 4 months)
Missed Therapy Sessions
Percentages of missed therapy sessions, due to low BP or concern for low BP development, in the usual care and BP treatment groups
Measured: Inpatient Hospitalizations (up to 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start1 Jun 2017
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- Jill M Wecht, Ed.D., Principal investigator, James J. Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919917
- Sponsor's protocol ID
- WEC-16-050
- Status last verified
- Feb 2025
- First submitted
- 22 Sep 2016
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 38712567Vaccaro 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.
PubMed 35366432
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Post-SCI Hypotension: A Randomized Controlled Study of Usual Care Versus Anti Hypotension Therapy
- ClinicalTrials.gov ID
- NCT02919917
- Acronym / sponsor ID
- WEC-16-050
- Conditions
- Spinal Cord Injury, Autonomic Dysreflexia, Orthostatic Hypotension, Baroreceptor Integrity, Sympathetic Integrity, Vagal Integrity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Experimental | Drug: Midodrine HydrochlorideIndividuals 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 . |
| BP Threshold Treatment Group | Experimental | Drug: Midodrine HydrochlorideIndividuals 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Any level of injury;
- Any AIS grade of SCI;
- Non-ventilator dependent
- Primarily wheelchair dependent for mobility;
- Duration of injury < 1 year
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midodrine HydrochlorideAlso: MidodrineLevel 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 | Drug | BP Threshold Treatment Group |
| Midodrine HydrochlorideAlso: MidodrineLevel 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 | Drug | Usual Care Group |
Primary outcome
Affected Therapy Sessions
Time frame: Inpatient hospitalization (up to 4 months)
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.
Systolic Blood Pressure
Time frame: Inpatient hospitalization (up to 4 months)
Systolic hypertension (>/= 140 mmHg)
2 secondary outcomes
Systolic Blood Pressure
Time frame: Inpatient Hospitalizations (up to 4 months)
Missed Therapy Sessions
Time frame: Inpatient Hospitalizations (up to 4 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38712567Wecht 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.
- Derived from this study: PubMed 35366432Vaccaro 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill M Wecht, Ed.D. principal investigator
James J. Peters VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Midodrine Hydrochloride in people with Spinal Cord Injury and Autonomic Dysreflexia, run by James J. Peters Veterans Affairs Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affected Therapy Sessions (time frame: Inpatient hospitalization (up to 4 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02919917, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.