Comparing heart medications for patients in cardiogenic shock
CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock
This study tests whether two heart medications, Dobutamine and Milrinone, can help critically ill patients in cardiogenic shock feel better compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 346 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 3 sites (Rochester, Minnesota and 2 other locations) |
| Trial ID | NCT05267886 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of inotropes, specifically Dobutamine and Milrinone, compared to a placebo in critically ill patients experiencing cardiogenic shock. Conducted as a multi-centre, double-blind, randomized control trial, it aims to determine if these medications can improve heart function and patient outcomes. Participants will be closely monitored, and medication dosages will be adjusted based on their clinical status. After 12 hours, treatment will transition to open label, allowing physicians to decide on continued inotrope use.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older who are admitted to an intensive care unit with SCAI class C or D cardiogenic shock.
Not a fit: Patients who are pregnant, have severe valvular lesions, or have recently received inotropes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for the safe and effective use of inotropes in treating cardiogenic shock, potentially improving patient survival and recovery.
How similar studies have performed: Previous studies have shown mixed results regarding the use of inotropes in cardiogenic shock, indicating that while some evidence exists for their use, the certainty of benefit remains low.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota and 2 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Not_yet_recruiting)
- Hamilton Health Sciences — Hamilton, Ontario, Canada (Recruiting)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Rebecca Mathew, MD — Ottawa Heart Institute Research Corporation
- Study coordinator: Rebecca Mathew, MD
- Email: rmathew@ottawaheart.ca
- Phone: 613-696-7406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.