Cardiocentric Inotropic Optimization in Spinal Cord Injury

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Dobutamine crossover

    Drug

    Cross-over from norepinephrine to dobutamine

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: Dobutamine CrossoverExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean arterial blood pressure

Time frame
From start to finish of cross-over procedures

Secondary outcomes

1

Cardiac stroke volume index

Time frame
from start to end of drug cross-over procedures

Other outcomes

Sponsors and contacts

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University of British Columbia

Lead sponsor

United States Department of Defense

Collaborator

This trial is not recruiting at the moment. You can still explore other options: