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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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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

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.

Christopher West, PhD contact

250 807 8891

chris.west@ubc.ca

Lucero Aceves, PhD contact

lucero.acevesserrano@ubc.ca

Canada1 site
  • Vancouver General Hospital

    Vancouver, British Columbia

    Allan Aludino, PhD, (604) 875-4111 ext. 61689, Allan.Aludino@vch.ca

Other trials in Canada

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.

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 groups in NCT07871643
Study groupRoleWhat they receive
Dobutamine CrossoverExperimentalThe 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.

  1. Mean arterial blood pressure

    Measured: From start to finish of cross-over procedures

Secondary outcomes (1)
  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.

  1. First posted13 Oct 2026
  2. Study startJun 2027 (estimated)
  3. Primary completionJun 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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)
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

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