[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659989":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":23,"studyPopulation":11,"armGroups":24,"interventions":31,"overallOfficials":11,"centralContacts":37,"locations":46,"responsibleParty":65,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of British Columbia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Mean arterial blood pressure",null,"From start to finish of cross-over procedures",[14],{"measure":15,"description":11,"timeFrame":16},"Cardiac stroke volume index","from start to end of drug cross-over procedures",{"allocation":18,"interventionModel":19,"interventionModelDescription":11,"primaryPurpose":20,"observationalModel":11,"timePerspective":11,"maskingInfo":21},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":22,"maskingDescription":11,"whoMasked":11},"NONE","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.\n\nRecruitment 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.",[25],{"label":26,"type":27,"description":28,"interventionNames":29},"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.",[30],"Drug: Dobutamine crossover",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"DRUG","Dobutamine crossover","Cross-over from norepinephrine to dobutamine",[26],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Christopher West, PhD","CONTACT","250 807 8891","chris.west@ubc.ca",{"name":44,"role":40,"phone":11,"phoneExt":11,"email":45},"Lucero Aceves, PhD","lucero.acevesserrano@ubc.ca",[47],{"facility":48,"status":11,"city":49,"state":50,"zip":11,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Vancouver General Hospital","Vancouver","British Columbia","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-123.11934,49.24966,{"lat":57,"lon":56},[60],{"name":61,"role":40,"phone":62,"phoneExt":63,"email":64},"Allan Aludino, PhD","(604) 875-4111","61689","Allan.Aludino@vch.ca",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Christopher West","Associate Professor",[70],{"name":71,"class":72},"United States Department of Defense","FED","100659989","early-phase-1-cardiocentric-inotropic-optimization-in-spinal-cord-injury-100659989",false,"NCT07871643","Cardiocentric Inotropic Optimization in Spinal Cord Injury","CARDIO-SCI","Inclusion Criteria:\n\n* Complete (AIS A) or incomplete (AIS B) acute traumatic SCI involving bony spinal levels between C0 and T1 (inclusive)\n* Able to communicate in English and provide informed consent\n\nExclusion Criteria:\n\n* History and\u002For symptoms of cardiovascular disease (Type 2 Diabetes is ok) or cardiopulmonary problems\u002Fdisease, including uncontrolled hypertension\n* Traumatic brain injury that is severe enough to preclude neurologic assessment of SCI impairment and assignment of AIS grade A or B.\n* Aneurysms of the thoracic aorta\n* Pregnant\n* Unstable Angina\n* Myocardial infarction in the preceding 2 days\n* Aortic stenosis\n* 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)\n* 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.\n* Any other medical condition that in the investigator's opinion would render the study procedures dangerous or impair your ability to receive study therapy","ALL","18 Years","75 Years",{"count":84,"type":85},8,"ESTIMATED","INTERVENTIONAL",[88],"EARLY_PHASE1","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.",[91],"SCI - Spinal Cord Injury",[93,94,95,96,97,98],"Blood Pressure","Dobutamine","Norepinephrine","Hemodynamic monitoring","Cardiac function","Acute management","NOT_YET_RECRUITING","2026-10-05",{"date":102,"type":103},"2026-10-13","ACTUAL",{"date":105,"type":85},"2027-06",{"date":107,"type":85},"2030-12",{"name":5,"class":6},1]