Milrinone Versus Dobutamine in Critically Ill Patients (NCT03207165) | Clinical Trial Compass
CompletedPhase 4
Milrinone Versus Dobutamine in Critically Ill Patients
Canada192 participantsStarted 2017-08-30
Plain-language summary
The investigators are interested in determining if there is a meaningful difference between two of the most commonly used medications used to improve the pumping function of the heart among critically ill patients admitted to the Coronary Care Unit (CCU) at the University of Ottawa Heart Institute (UOHI). To do this, the investigators will randomly assign patients who are felt to require use of these medications by their treating physicians to one of the two most commonly used agents in Canada: Milrinone or Dobutamine. Each patient will be closely monitored by their healthcare team, and their medication will be adjusted based on each patient's clinical status. Information from blood work (e.g. kidney and liver function, complete blood counts, and other markers of how effectively blood is circulating in the body), assessment of end-organ function (e.g. urine output, mentation), abnormal heart rhythms noted on monitoring and results of imaging studies (e.g. angiogram, echocardiograms.) will be collected for analysis. All patients will be followed for the duration of their hospital stay at UOHI.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have one or more of the following:
* Low cardiac output state, evidenced by sustained hypotension (systolic blood pressure \<90 mmHg) and end organ dysfunction (altered level of consciousness, elevated lactate, renal or hepatic dysfunction)
* Clinical evidence of systemic and/or pulmonary congestion despite use of vasodilators and/or diuretics
* ACS complicated by cardiogenic shock (defined as persistent hypotension with systolic blood pressure \<90 mmHg with severe reduction in cardiac index \[\<1.8 L/min/m2 without support or \<2.2 L/min/m2 with support\], left ventricular end-diastolic pressure \>18 mmHg)
* Augmentation of cardiac output when patient already on maximal vasopressor therapy
* Or medical team's decision that patient needs inotropic therapy
Exclusion Criteria:
* Unwillingness or inability to provide informed consent by the patient or substitute decision maker for healthcare decisions
* Female participants who are currently pregnant
* Patients presenting with an out-of-hospital cardiac arrest (OOHCA)
* Healthcare team preference for use of specific inotrope (Milrinone or Dobutamine)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite Primary End Point
Timeframe: Through duration of hospitalization, up to 12 weeks following admission
2
All-cause in-hospital death
Timeframe: Through duration of hospitalization, up to 12 weeks following admission
3
Non-fatal myocardial infarction [MI]
Timeframe: Through duration of hospitalization, up to 12 weeks following admission
4
Transient ischemic attack [TIA] or cerebrovascular accident [CVA]
Timeframe: Through duration of hospitalization, up to 12 weeks following admission
5
Stay in CCU greater than or equal to 7 days
Timeframe: Through duration of hospitalization, up to 12 weeks following admission
Timeframe: Through duration of hospitalization, up to 12 weeks following admission
7
Need for advanced mechanical support [specifically, intra-aortic balloon pump, Impella, ventricular assist device or extra-corporeal membrane oxygenation] or cardiac transplant
Trial details
NCT IDNCT03207165
SponsorOttawa Heart Institute Research Corporation