CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

Condition(s) studied

Investigational drug(s) / intervention(s)

Dobutamine: Dobutamine administered according to its clinical dose stage for cardiogenic shock

Milrinone: Milrinone administered according to its clinical dose stage for cardiogenic shock

Normal Saline: Normal saline running at a standardized rate

Study 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.

Eligibility

Primary outcome measure(s)

• Primary composite outcome — Through duration of hospitalization, up to 12 weeks following admission
  The primary outcome will be a composite of: 1. All-cause mortality during the hospitalization 2. Measured within the first 12 hours of starting the study intervention, any of: 1. Sustained hypotension (mean arterial pressure ≤55mmHg) or sustained requirement of high dose vasopressors (norepinephrine \>0.2 mcg/kg/min or norepinephrine 0.2 mcg/kg/min plus any additional agent) with any escalation in dose from time of randomization, for \>/= 60 minutes 2. Lactate greater than 3.5 mmol/L at 6 hours or thereafter 3. Need for mechanical circulatory support device 4. Atrial or ventricular arrhythmia leading to emergent electrical cardioversion 5. Resuscitated cardiac arrest

Trial sites (3)

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