An Early Phase 1 interventional study of Dobutamine crossover in SCI - Spinal Cord Injury, sponsored by University of British Columbia. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by University of British Columbia · Early Phase 1, Interventional, and Supportive care
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.
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.
1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.
This study's planned enrollment of 8 is below the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of British Columbia is the lead sponsor of 1,335 studies on the registry; 256 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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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.
Drug: Dobutamine crossover
Cross-over from norepinephrine to dobutamine
Mean arterial blood pressure
Time frame: From start to finish of cross-over procedures
Cardiac stroke volume index
Time frame: from start to end of drug cross-over procedures
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2027; primary completion for Jun 2030, 36 months later.
Of 47 phase 1 interventional studies under Spinal Cord Injuries, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 36 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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