[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459843":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":42,"locations":52,"responsibleParty":113,"collaborators":33,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":33,"enrollmentInfo":124,"targetDuration":33,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":77,"whyStopped":33,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Ottawa Heart Institute Research Corporation","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Inotrope","ACTIVE_COMPARATOR","Participants randomized to receive the inotrope will be initiated on inotrope therapy at starting doses and titrated according to standard clinical care. During reassessment, the treating physicians will make a decision about adjustment of the inotrope dose (increase, maintain or decrease) based on hemodynamics, end-organ perfusion, vasopressor support and clinical exam. Dobutamine doses will be 2.5, 5.0, 7.5, 10 and \\>10 ug\u002Fkg\u002Fmin and milrinone doses will be 0.125, 0.250, 0.375, 0.5 and \\>0.5 ug\u002Fkg\u002Fmin. These dose stages are identical to those used in Capital Do-Re-Mi and reflect current standard of care.",[13,14],"Drug: Dobutamine","Drug: Milrinone",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo","PLACEBO_COMPARATOR","Participants in the placebo arm will have an intravenous solution of 0.9% NaCl running at a standardized rate, comparable to the infusion rate of the inotrope arm.",[20],"Drug: Normal Saline",[22,29,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Dobutamine","Dobutamine administered according to its clinical dose stage for cardiogenic shock",[9],[28],"Dobutrex, Inotrex",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Milrinone","Milrinone administered according to its clinical dose stage for cardiogenic shock",[9],null,{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Normal Saline","Normal saline running at a standardized rate",[16],[39],{"name":40,"affiliation":5,"role":41},"Rebecca Mathew, MD","PRINCIPAL_INVESTIGATOR",[43,47],{"name":40,"role":44,"phone":45,"phoneExt":33,"email":46},"CONTACT","613-696-7406","rmathew@ottawaheart.ca",{"name":48,"role":44,"phone":49,"phoneExt":50,"email":51},"Baylie Morgan, RN","613-696-7000","19059","bmorgan@ottawaheart.ca",[53,75,99],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Mayo Clinic","NOT_YET_RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-92.4699,44.02163,{"lat":65,"lon":64},[68,71,72],{"name":69,"role":44,"phone":33,"phoneExt":33,"email":70},"Benjamin M Hibbert, MD, PhD","hibbert.benjamin@mayo.edu",{"name":69,"role":41,"phone":33,"phoneExt":33,"email":33},{"name":73,"role":74,"phone":33,"phoneExt":33,"email":33},"Jacob C Jentzer, MD","SUB_INVESTIGATOR",{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Hamilton Health Sciences","RECRUITING","Hamilton","Ontario","L8L 2X2","Canada","CA",{"type":62,"coordinates":84},[85,86],-79.84963,43.25011,{"lat":86,"lon":85},[89,92,93,95,97],{"name":90,"role":44,"phone":91,"phoneExt":33,"email":33},"Emilie Belley-Cote, MD","905-521-2100",{"name":90,"role":41,"phone":33,"phoneExt":33,"email":33},{"name":94,"role":74,"phone":33,"phoneExt":33,"email":33},"Richard Whitlock, MD",{"name":96,"role":74,"phone":33,"phoneExt":33,"email":33},"Craig Ainsworth, MD",{"name":98,"role":74,"phone":33,"phoneExt":33,"email":33},"Faizan Amin, MD",{"facility":100,"status":77,"city":101,"state":79,"zip":102,"country":81,"countryCode":82,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"University of Ottawa Heart Institute","Ottawa","K1Y4W7",{"type":62,"coordinates":104},[105,106],-75.69812,45.41117,{"lat":106,"lon":105},[109,110,111],{"name":40,"role":44,"phone":45,"phoneExt":33,"email":46},{"name":40,"role":41,"phone":33,"phoneExt":33,"email":33},{"name":112,"role":74,"phone":33,"phoneExt":33,"email":33},"Pietro Di Santo, MD",{"type":114,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100459843","phase-4-capital-doremi-2-inotrope-versus-placebo-therapy-for-cardiogenic-shock-100459843",false,"NCT05267886","CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock","DOREMI-2","Inclusion Criteria:\n\n* Adult patients ≥ 18 years of age admitted to an intensive care unit\n* SCAI class C or D cardiogenic shock\n\nExclusion Criteria:\n\n* Unwilling or unable to obtain informed consent by the participant or substitute decision maker\n* Patients who are currently pregnant or breast-feeding\n* Patients presenting with an out-of-hospital cardiac arrest (OHCA)\n* Administration of milrinone or dobutamine in the 24 hours preceding anticipated randomization\n* Severe obstructive valvular lesions, including aortic stenosis and\u002For mitral stenosis\n* Dynamic left ventricular outflow tract obstruction","ALL","18 Years",{"count":125,"type":126},346,"ESTIMATED","INTERVENTIONAL",[129],"PHASE4","The investigators are interested in determining if there is a meaningful benefit from the use of medications purported to increase the pumping function of the heart (i.e. inotropes) among critically ill patients admitted to the Cardiac Intensive Care Unit (CICU). To do this, the investigators will conduct a multi-centre, double blind, randomized control trial with patients who are deemed to require these medications by their treating physician to one of the two most commonly used agents in Canada (Milrinone or Dobutamine) or placebo. Each patient will be closely monitored by their healthcare team. The dose of medication will be adjusted according to each patients' clinical status. After 12 hours, the participants will move to open label treatment and any continued use of inotropes will be at the discretion of their treating physician.",[132],"Shock, Cardiogenic",[134,135,136],"cardiogenic","shock","inotrope","2026-04-27",{"date":139,"type":140},"2026-05-01","ACTUAL",{"date":142,"type":140},"2022-03-05",{"date":144,"type":126},"2026-12",{"name":5,"class":6},3]