Actively Recruiting
CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock
Led by Ottawa Heart Institute Research Corporation · Updated on 2026-05-01
346
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of medications called inotropes, which aim to increase the heart's pumping ability, in critically ill patients admitted to the Cardiac Intensive Care Unit with cardiogenic shock. Cardiogenic shock is a serious condition caused by the heart's inability to pump enough blood, commonly due to acute heart attacks, and it has a high risk of death. This trial seeks to determine whether inotropes improve outcomes or potentially cause harm, as previous studies showed uncertain benefits and possible risks. Participants will be randomly assigned to receive either one of two common inotropes used in Canada, Milrinone or Dobutamine, or a placebo (normal saline) in a double-blind setup. Doses of the inotropes will start at standard levels and be adjusted based on each patient's condition by their doctors. After 12 hours, treatment becomes open-label, allowing doctors to continue or stop inotropes as needed. The study compares these therapies during initial resuscitation in patients classified as SCAI class C or D cardiogenic shock. During the study, patients will be closely monitored with assessments including clinical exams and adjustments to medication doses. Researchers will track outcomes such as mortality, kidney failure needing dialysis, need for heart transplant or mechanical support, heart rhythm problems, cardiac arrest, heart attacks, and strokes during hospitalization, up to 12 weeks. The trial involves multiple centers and aims to provide clear evidence on the use of inotropes in this critical care setting.
CONDITIONS
Brief Title
CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years of age or older admitted to an intensive care unit
- Diagnosed with SCAI class C or D cardiogenic shock
You will not qualify if you...
- Unwilling or unable to provide informed consent by the participant or substitute decision maker
- Currently pregnant or breastfeeding
- Presenting with an out-of-hospital cardiac arrest
- Received milrinone or dobutamine in the 24 hours prior to anticipated randomization
- Severe obstructive valvular lesions, including aortic stenosis and/or mitral stenosis
- Dynamic left ventricular outflow tract obstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks or until hospital discharge
Participants receive either inotrope therapy or placebo according to their assigned group, with dose adjustments based on clinical assessments to manage cardiogenic shock.
Daily assessments during hospitalization
Trial Site Locations
Total: 3 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
2
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
3
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7
Actively Recruiting
Research Team
R
Rebecca Mathew, MD
B
Baylie Morgan, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here