CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Treatments: Dobutamine; Milrinone

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