SCI - Spinal Cord InjuryEarly Phase 1CARDIO-SCINCT07871643
Cardiocentric Inotropic Optimization in Spinal Cord Injury
A Early Phase 1 study testing Dobutamine crossover in people with SCI - Spinal Cord Injury, run by University of British Columbia at 1 site in Canada.
Trial summary
The first hours-to-day following acute traumatic cervical SCI represent a critical period of time to optimize hemodynamic management. After a spinal cord injury, cardiovascular function is affected. Maintaining blood pressure becomes is an important part of treatment as it supports recovery of the injured spinal cord. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- Dobutamine crossover
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2027to Dec 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complete (AIS A) or incomplete (AIS B) acute traumatic SCI involving bony spinal levels between C0 and T1 (inclusive)
- Able to communicate in English and provide informed consent
Who cannot join
- History and/or symptoms of cardiovascular disease (Type 2 Diabetes is ok) or cardiopulmonary problems/disease, including uncontrolled hypertension
- Traumatic brain injury that is severe enough to preclude neurologic assessment of SCI impairment and assignment of AIS grade A or B.
- Aneurysms of the thoracic aorta
- Pregnant
- Unstable Angina
- Myocardial infarction in the preceding 2 days
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- Aortic stenosis
- Any patient who requires additional vasopressor infusions other than NE within 4 hours of the time that the crossover is to be conducted will be excluded and considered a screen-fail (i.e. at the time of the crossover, the participant must only be on norepinephrine for blood pressure control and maintained solely on norepinephrine for the 4 hours preceding the crossover)
- Any patient who does not have an arterial line and central venous catheter (CVC) inserted as part of their standard clinical management at the time the crossover is to be conducted will be excluded and considered a screen-fail.
- Any other medical condition that in the investigator's opinion would render the study procedures dangerous or impair your ability to receive study therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lucero Aceves, PhD contact
Canada1 site
Vancouver General Hospital
Vancouver, British Columbia
Allan Aludino, PhD, (604) 875-4111 ext. 61689, Allan.Aludino@vch.ca
About this study
The first hours-to-day following acute traumatic cervical SCI represent a critical period of time to optimize hemodynamic management. After a spinal cord injury, cardiovascular function is affected. Maintaining blood pressure becomes is an important part of treatment as it supports recovery of the injured spinal cord. Blood pressure is most often increased using vasopressors, such as norepinephrine. Although these drugs help maintain blood flow, they may also lead to increased bleeding in the injury site, making the lesion worse. Alternatively, dobutamine, a medication that helps the heart pump more effectively, has shown to maintain blood pressure and improve prefusion at the injury site. This study will assess dobutamine capacity to maintain blood pressure acutely post injury.
Read the detailed description
This is a pilot study in which the efficacy of Dobutamine (DOB) will be evaluated within 48 hours post-surgery in acute cervical SCI participants. A total of 8 participants between 18-75 years of age who have sustained an acute traumatic cervical SCI prior will be recruited from the emergency department, intensive care unit, post anesthesia care unit, or spine stepdown unit.
Recruitment will be isolated to those individuals who require an arterial line as part of standard clinical care, and who will (or already are) receive(ing) norepinephrine (NE) as part of their standard clinical hemodynamic management. In addition to the standard clinical measurements, we will utilize right-heart catheterization to measure continuous cardiac output and non-invasive transthoracic echocardiography to measure left ventricular (LV) structure and function. All study procedures will be conducted in the intensive care unit within the first 48 hours after surgery and will be completed over a 2.5hr period. The main procedure in this study is a "cross-over" from NE to DOB, in which we will assess cardiac function while switching the hemodynamic management from NE to DOB. After spine surgery, but before the start of the cross-over, an Intensivist will place a right-heart catheter. With the right heart catheter in situ, the research nurse will record baseline blood pressure, heart rate, and cardiac output over a 15-min period. A research sonographer will then perform a comprehensive baseline echocardiography exam. Next, we will begin infusion of DOB and gradually wean the patient off of NE (the "cross-over"). The DOB will be titrated to maintain the baseline MAP for a period of 35-40 minutes whilst simultaneously titrating the NE down, to the point where the participant's blood pressure will be maintained solely on DOB. When the participant is solely on DOB, an abbreviated 2nd echocardiography exam will be performed, approximately 20 min after blood pressure support has been achieved with DOB alone. Following completion of the echocardiography exam, we will begin infusion of NE and titrate this up, whilst simultaneously gradually titrating down the DOB to wean the patient fully off of DOB (i.e. cross-over from DOB back to NE alone). Following 20 min of transition back to exclusive management with NE, we will conduct an abbreviated 3rd echocardiography exam. The right-heart catheter will then be removed unless there is a clinical indication to keep the right-heart catheter in place.
- Conditions
- SCI - Spinal Cord Injury
- Being tested
- Dobutamine crossover
- Keywords
- Blood Pressure, Dobutamine, Norepinephrine, Hemodynamic monitoring, Cardiac function, Acute management
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dobutamine crossoverDrug
Cross-over from norepinephrine to dobutamine
| Study group | Role | What they receive |
|---|---|---|
| Dobutamine Crossover | Experimental | The main procedure in this study is a "cross-over" from NE to DOB, in which we will assess cardiac function while switching the hemodynamic management from NE to DOB. Receives: Drug: Dobutamine crossover |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood pressure
Measured: From start to finish of cross-over procedures
Secondary outcomes (1)
Cardiac stroke volume index
Measured: from start to end of drug cross-over procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startJun 2027 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Christopher West, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871643
- Sponsor's protocol ID
- H25-04145
- Acronym
- CARDIO-SCI
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiocentric Inotropic Optimization in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07871643
- Acronym / sponsor ID
- CARDIO-SCI / H25-04145
- Conditions
- SCI - Spinal Cord Injury
- Keywords
- Blood Pressure, Dobutamine, Norepinephrine, Hemodynamic monitoring, Cardiac function, Acute management
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jun 2027 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The first hours-to-day following acute traumatic cervical SCI represent a critical period of time to optimize hemodynamic management. After a spinal cord injury, cardiovascular function is affected. Maintaining blood pressure becomes is an important part of treatment as it supports recovery of the injured spinal cord. Blood pressure is most often increased using vasopressors, such as norepinephrine. Although these drugs help maintain blood flow, they may also lead to increased bleeding in the injury site, making the lesion worse. Alternatively, dobutamine, a medication that helps the heart pump more effectively, has shown to maintain blood pressure and improve prefusion at the injury site. This study will assess dobutamine capacity to maintain blood pressure acutely post injury.
Detailed description
This is a pilot study in which the efficacy of Dobutamine (DOB) will be evaluated within 48 hours post-surgery in acute cervical SCI participants. A total of 8 participants between 18-75 years of age who have sustained an acute traumatic cervical SCI prior will be recruited from the emergency department, intensive care unit, post anesthesia care unit, or spine stepdown unit.
Recruitment will be isolated to those individuals who require an arterial line as part of standard clinical care, and who will (or already are) receive(ing) norepinephrine (NE) as part of their standard clinical hemodynamic management. In addition to the standard clinical measurements, we will utilize right-heart catheterization to measure continuous cardiac output and non-invasive transthoracic echocardiography to measure left ventricular (LV) structure and function. All study procedures will be conducted in the intensive care unit within the first 48 hours after surgery and will be completed over a 2.5hr period. The main procedure in this study is a "cross-over" from NE to DOB, in which we will assess cardiac function while switching the hemodynamic management from NE to DOB. After spine surgery, but before the start of the cross-over, an Intensivist will place a right-heart catheter. With the right heart catheter in situ, the research nurse will record baseline blood pressure, heart rate, and cardiac output over a 15-min period. A research sonographer will then perform a comprehensive baseline echocardiography exam. Next, we will begin infusion of DOB and gradually wean the patient off of NE (the "cross-over"). The DOB will be titrated to maintain the baseline MAP for a period of 35-40 minutes whilst simultaneously titrating the NE down, to the point where the participant's blood pressure will be maintained solely on DOB. When the participant is solely on DOB, an abbreviated 2nd echocardiography exam will be performed, approximately 20 min after blood pressure support has been achieved with DOB alone. Following completion of the echocardiography exam, we will begin infusion of NE and titrate this up, whilst simultaneously gradually titrating down the DOB to wean the patient fully off of DOB (i.e. cross-over from DOB back to NE alone). Following 20 min of transition back to exclusive management with NE, we will conduct an abbreviated 3rd echocardiography exam. The right-heart catheter will then be removed unless there is a clinical indication to keep the right-heart catheter in place.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dobutamine Crossover | Experimental | Drug: Dobutamine crossoverThe main procedure in this study is a "cross-over" from NE to DOB, in which we will assess cardiac function while switching the hemodynamic management from NE to DOB. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Complete (AIS A) or incomplete (AIS B) acute traumatic SCI involving bony spinal levels between C0 and T1 (inclusive)
- Able to communicate in English and provide informed consent
Key exclusion criteria (10 listed)
- History and/or symptoms of cardiovascular disease (Type 2 Diabetes is ok) or cardiopulmonary problems/disease, including uncontrolled hypertension
- Traumatic brain injury that is severe enough to preclude neurologic assessment of SCI impairment and assignment of AIS grade A or B.
- Aneurysms of the thoracic aorta
- Pregnant
- Unstable Angina
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 |
|---|---|---|
| Dobutamine crossoverCross-over from norepinephrine to dobutamine | Drug | Dobutamine Crossover |
Primary outcome
Mean arterial blood pressure
Time frame: From start to finish of cross-over procedures
1 secondary outcome
Cardiac stroke volume index
Time frame: from start to end of drug cross-over procedures
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Lucero Aceves, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dobutamine crossover in people with SCI - Spinal Cord Injury, run by University of British Columbia at 1 site in Canada.
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 2 inclusion and 10 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: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher West, PhD (250 807 8891, chris.west@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial blood pressure (time frame: From start to finish of cross-over procedures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.