[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563763":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":30,"responsibleParty":37,"collaborators":41,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":30,"enrollmentInfo":54,"targetDuration":30,"studyType":57,"phases":58,"briefSummary":61,"conditions":62,"keywords":30,"overallStatus":65,"whyStopped":30,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":30},{"fullName":5,"class":6},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine","EXPERIMENTAL","DEX (4 mcg\u002F100 ml supplied by Juno Pharmaceuticals) will be initiated at a starting dose of 0.6 mcg\u002Fkg\u002Fhour and increased by 0.2 mcg\u002Fkg\u002Fhour every 30 minutes up to final dose of 1.4 mcg\u002Fkg\u002Fhour.",[13],"Drug: Dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Matching placebo (NS 0.9% 100ml)",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","DEX 4 mcg\u002F100 ml at a starting dose of 0.6 mcg\u002Fkg\u002Fhour and increased by 0.2 mcg\u002Fkg\u002Fhour every 30 minutes up to final dose of 1.4 mcg\u002Fkg\u002Fhour.",[9],[26],"Precedex",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"NaCl 0.9% 100ml",[15],null,[32],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Virginie Williams, PhD","CONTACT","514-338-2222","virginie.williams.cnmtl@ssss.gouv.qc.ca",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","David Williamson","Full Clinical Professor",[42],{"name":43,"class":6},"Canadian Critical Care Trials Group","100563763","phase-2-effects-of-dexmedetomidine-on-agitation-in-critically-ill-tbi-patients-100563763",false,"NCT06620393","Effects of Dexmedetomidine on Agitation in Critically Ill TBI Patients","Effects of Dexmedetomidine on Agitation in Critically Ill TBI Patients (DEX-TBI)","DEX-TBI","Inclusion Criteria:\n\n1. Adults (≥18 years) admitted to ICU with a critically ill moderate or severe TBI patients. Severity of TBI will be determined with the first Glasgow Coma Score (GCS). TBI patients with polytrauma and patients undergoing neurosurgical interventions will be eligible.\n2. Undergoing mechanically ventilation (of any duration) at the time of assessment.\n3. Anticipated ICU stay of 48 hours or more.\n\nExclusion Criteria:\n\n1. Patients at very high risk of short-term mortality (e.g., GCS of 3 without sedation, or unreactive pupils, or declared brain-dead when assessed for eligibility and patients in whom there is a lack of commitment to ongoing life support\n2. Patients unable to communicate in English or French (interfering with posttraumatic amnesia assessments)\n3. Patients with cognitive impairment as per family evaluation\n4. Pregnant or breastfeeding\n5. Patients currently receiving DEX or clonidine\n6. Allergy, bradycardia or hypotension precluding use of dexmedetomidine as per treating physician","ALL","18 Years",{"count":55,"type":56},72,"ESTIMATED","INTERVENTIONAL",[59,60],"PHASE2","PHASE3","Agitation is a frequent complication following traumatic braing injury in patients admitted to the intensive care unit. This agitation frequently results in the liberal use of rescue drugs such as antipsychotics, sedatives and opiates, which in turn may delay rehabilitation, liberation from mechanical ventilation and emergence from posttraumatic amnesia. Dexmedetomidine may be a better agent given it's light sedative properties. The main objective is to assess the feasibility of conducting a multicenter randomized controlled trial of dexmedetomidine following TBI in the ICU.",[63,64],"Traumatic Brain Injury","Agitation,Psychomotor","NOT_YET_RECRUITING","2024-09-27",{"date":68,"type":69},"2024-10-01","ACTUAL",{"date":68,"type":56},{"date":72,"type":56},"2026-12-01",{"name":5,"class":6}]