CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Feb 23, 2022

Keywords

ClinConnect Summary

The CAPITAL DOREMI 2 trial is studying whether certain medications that help improve heart function, called inotropes, provide any real benefits for critically ill patients experiencing cardiogenic shock, a serious condition where the heart cannot pump enough blood to meet the body's needs. In this research, patients admitted to the Cardiac Intensive Care Unit (CICU) will be randomly assigned to receive either one of two commonly used inotropes (Milrinone or Dobutamine) or a placebo (a treatment that looks like the real medication but has no active ingredients). The healthcare team will closely monitor each patient and adjust the medication based on their condition. After 12 hours, patients will switch to open-label treatment, meaning they will receive the medication their doctor thinks is best.

To participate in this trial, you must be an adult aged 18 or older and have a certain level of cardiogenic shock, classified as SCAI class C or D. However, some individuals, including those who are pregnant, unable to consent, or have specific heart conditions, may not be eligible. If chosen to participate, you can expect to be part of a structured study where your health will be monitored closely, contributing valuable information to help improve treatments for heart conditions in the future.

Gender

ALL

Eligibility 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