CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock (DOREMI-2)
Shock, Cardiogenic
About this trial
This is an interventional treatment trial for Shock, Cardiogenic focused on measuring cardiogenic, shock, inotrope
Eligibility Criteria
Inclusion Criteria:
- Adult patients ≥ 18 years of age admitted to an intensive care unit
- SCAI class C or D cardiogenic shock
Exclusion Criteria:
- Unwilling or unable to obtain informed consent by the participant or substitute decision maker
- Patients who are currently pregnant or breast-feeding
- Patients presenting with an out-of-hospital cardiac arrest (OHCA)
- Administration of milrinone or dobutamine in the 24 hours preceding anticipated randomization
- Severe obstructive valvular lesions, including aortic stenosis and/or mitral stenosis
- Dynamic left ventricular outflow tract obstruction
Sites / Locations
- University of Ottawa Heart InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Inotrope
Placebo
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/kg/min and milrinone doses will be 0.125, 0.250, 0.375, 0.5 and >0.5 ug/kg/min. These dose stages are identical to those used in Capital Do-Re-Mi and reflect current standard of care.
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.