CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock
Ottawa Heart Institute Research Corporation
Summary
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.
Description
Cardiogenic shock (CS) is a state of inadequate end-organ perfusion due to cardiac dysfunction. Acute myocardial infarction (AMI) remains the most prevalent cause of CS, with mortality reaching upwards of 40% despite advances in emergent revascularization and accelerating use of mechanical circulatory support devices. International guidelines support the use of vasopressors and inotropes as a mainstay of medical therapy among this cohort of critically ill patients. Recently, the first head-to-head prospective randomized trial (CAPITAL DOREMI) comparing milrinone and dobutamine in a cohort of C…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 obs…
Interventions
- DrugDobutamine
Dobutamine administered according to its clinical dose stage for cardiogenic shock
- DrugMilrinone
Milrinone administered according to its clinical dose stage for cardiogenic shock
- DrugNormal Saline
Normal saline running at a standardized rate
Locations (3)
- Mayo ClinicRochester, Minnesota
- Hamilton Health SciencesHamilton, Ontario
- University of Ottawa Heart InstituteOttawa, Ontario