Inotrope Therapy for Cardiogenic Shock
(DOREMI-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing whether drugs that help the heart pump better are beneficial for very sick patients with severe heart problems. These patients are in intensive care because their hearts can't pump enough blood. The study will compare two common drugs, Milrinone and Dobutamine, to see if they improve patient outcomes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is inotrope therapy with milrinone or dobutamine safe for humans?
Milrinone and dobutamine are generally safe for humans, but they can have different side effects. Milrinone may cause low blood pressure, while dobutamine may lead to irregular heartbeats. Both drugs have been used safely in patients with heart conditions, but the choice between them often depends on which side effects are more tolerable for the patient.12345
How do the drugs dobutamine and milrinone differ from other treatments for cardiogenic shock?
Dobutamine and milrinone are unique in their ability to improve heart function by increasing the strength of heart contractions, which can help stabilize patients with cardiogenic shock. Unlike some other treatments, they are administered intravenously (through a vein) and are often chosen based on their different side effect profiles, with dobutamine more likely to cause arrhythmias (irregular heartbeats) and milrinone more likely to cause hypotension (low blood pressure).23456
What data supports the effectiveness of the drugs Dobutamine and Milrinone for treating cardiogenic shock?
Research shows that both Dobutamine and Milrinone are effective in resolving cardiogenic shock, with similar success rates and time to resolution. However, they have different side effects, with Dobutamine more likely to cause irregular heartbeats and Milrinone more likely to cause low blood pressure.12356
Who Is on the Research Team?
Rebecca Mathew, MD
Principal Investigator
Ottawa Heart Institute Research Corporation
Are You a Good Fit for This Trial?
This trial is for adults over 18 in intensive care with a severe form of heart failure called cardiogenic shock. It's not for pregnant or breastfeeding individuals, those who can't consent, had an out-of-hospital cardiac arrest, took certain heart medications recently, or have specific severe heart valve problems.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive inotrope or placebo therapy for cardiogenic shock, with doses adjusted based on clinical status
Open-label Treatment
Participants move to open-label treatment where continued use of inotropes is at the discretion of the treating physician
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dobutamine
- Milrinone
- Normal Saline
Dobutamine is already approved in United States, European Union, Canada for the following indications:
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Who Is Running the Clinical Trial?
Ottawa Heart Institute Research Corporation
Lead Sponsor