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RECRUITINGPhase 4INTERVENTIONAL

CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adult patients ≥ 18 years of age admitted to an intensive care unit - SCAI class C or D cardiogenic shock Who Should NOT Join This Trial: - Unwilling or unable to obtain willing to sign a consent form 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Dobutamine

Dobutamine administered according to its clinical dose stage for cardiogenic shock

DRUG

Milrinone

Milrinone administered according to its clinical dose stage for cardiogenic shock

DRUG

Normal Saline

Normal saline running at a standardized rate

Locations (3)

Mayo Clinic
Rochester, Minnesota, United States
Hamilton Health Sciences
Hamilton, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada