A Phase 4 interventional study of Dobutamine and Milrinone in Shock, Cardiogenic, sponsored by Ottawa Heart Institute Research Corporation. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Ottawa Heart Institute Research Corporation · Phase 4, Interventional, and Treatment
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.
Cardiogenic shock (CS) is a state of inadequate end-organ perfusion due to cardiac dysfunction. Acute myocardial infarction (AMI) remains the most prevalent cause of CS, with mortality reaching upwards of 40% despite advances in emergent revascularization and accelerating use of mechanical circulatory support devices. International guidelines support the use of vasopressors and inotropes as a mainstay of medical therapy among this cohort of critically ill patients. Recently, the first head-to-head prospective randomized trial (CAPITAL DOREMI) comparing milrinone and dobutamine in a cohort of CS participants was performed and found no difference between agents.
There is a signal of harm associated with the use of inotropes in both acute, decompensated heart failure and in the longitudinal management of chronic heart failure. Inotrope use has also been associated with longer ICU and in-hospital length of stay, as well as higher in-hospital mortality. A recent network meta-analysis on treatment strategies in CS and found that while milrinone and dobutamine may reduce the risk of mortality compared to placebo, the evidence is of low certainty and the wide confidence intervals do not rule out the possibility of harm.
Despite their frequent use in the management of patients with CS, it remains unknown if inotropes are needed to augment successful initial resuscitation, reduce morbidity and mortality, or if they cause potential harm in this already critically ill patient population.
This study is a multi-centre, double blind, randomized controlled trial designed to examine the efficacy and safety of inotrope therapy against placebo in the initial resuscitation of SCAI class C to D cardiogenic shock. Consecutive patients admitted to an intensive care unit will be identified by the treating medical team as requiring new initiation of inotrope therapy for CS. All decisions to initiate inotrope therapy will be made by the primary care team with no involvement from the research team. The study hypothesis is that inotrope therapy will lead to an overall improvement in the primary outcome as compared to placebo.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
This study's planned enrollment of 346 is above the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →Ottawa Heart Institute Research Corporation is the lead sponsor of 182 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to receive the inotrope will be initiated on inotrope therapy at starting doses and titrated according to standard clinical care. During reassessment, the treating physicians will make a decision about adjustment of the inotrope dose (increase, maintain or decrease) based on hemodynamics, end-organ perfusion, vasopressor support and clinical exam. Dobutamine doses will be 2.5, 5.0, 7.5, 10 and \>10 ug/kg/min and milrinone doses will be 0.125, 0.250, 0.375, 0.5 and \>0.5 ug/kg/min. These dose stages are identical to those used in Capital Do-Re-Mi and reflect current standard of care.
Drug: Dobutamine · Drug: Milrinone
Participants in the placebo arm will have an intravenous solution of 0.9% NaCl running at a standardized rate, comparable to the infusion rate of the inotrope arm.
Drug: Normal Saline
Dobutamine administered according to its clinical dose stage for cardiogenic shock
Also known as: Dobutrex, Inotrex
Milrinone administered according to its clinical dose stage for cardiogenic shock
Normal saline running at a standardized rate
Primary composite outcome
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
Time frame: Through duration of hospitalization, up to 12 weeks following admission
All-cause in-hospital mortality
Death resulting from any cause during hospitalization
Time frame: Through duration of hospitalization, up to 12 weeks following admission
Renal failure requiring new initiation of renal replacement therapy
Requiring new initiation of renal replacement therapy
Time frame: Through duration of hospitalization, up to 12 weeks following admission
Need for cardiac transplant or mechanical circulatory support
Identification of needing a cardiac transplant or mechanical circulatory support
Time frame: Through duration of hospitalization, up to 12 weeks following admission
Atrial or ventricular arrhythmia leading to emergent electrical cardioversion
Requiring emergent electrical cardioversion for atrial or ventricular arrhythmia
Time frame: Through duration of hospitalization, up to 12 weeks following admission
Resuscitated cardiac arrest
Cardiopulmonary arrest requiring chest compressions and/or defibrillation with successful return of spontaneous circulation (ROSC)
Time frame: Through duration of hospitalization, up to 12 weeks following admission
Non-fatal myocardial infarction
Non-fatal myocardial infarction
Time frame: Through duration of hospitalization, up to 12 weeks following admission
Stroke or transient ischemic attack
Defined as an episode of focal or global neurological deficit as diagnosed by a neurologist
Time frame: Through duration of hospitalization, up to 12 weeks following admission
Need for non-invasive or invasive mechanical ventilation
Need for non-invasive or invasive mechanical ventilation after randomization
Time frame: Through duration of hospitalization, up to 12 weeks following admission
Arrhythmia requiring pharmacologic intervention
Atrial or ventricular arrhythmias requiring initiation of pharmacologic intervention (intravenous or oral anti-arrhythmic therapy)
Time frame: Through duration of hospitalization, up to 12 weeks following admission
Acute kidney injury
Acute kidney injury
Time frame: Through duration of hospitalization, up to 12 weeks following admission
Plan to share: Yes — The study data, protocol, SAP, ICF, and CSR will be made available at study completion/publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Study completion
Access criteria: The above will be made publicly available
No publications or documents are linked to this record.
Started Mar 2022 (actual). Primary completion is estimated for Dec 2026, 57 months after the start.
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Studies of the drugs tested here: Dobutamine · Milrinone
Ottawa Heart Institute Research Corporation →