CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

Description

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.

Conditions

Shock, Cardiogenic

Study Overview

Study Details

Study overview

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.

CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

Condition
Shock, Cardiogenic
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adult patients ≥ 18 years of age admitted to an intensive care unit
  • * SCAI class C or D cardiogenic shock
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ottawa Heart Institute Research Corporation,

Rebecca Mathew, MD, PRINCIPAL_INVESTIGATOR, Ottawa Heart Institute Research Corporation

Study Record Dates

2026-12