About this trial
The goal of this multicenter, open-label, randomized clinical trial is to learn whether norepinephrine or dopamine is more effective and safer as the first-line vasoactive drug for treating cardiogenic shock in adults. Cardiogenic shock is a life-threatening condition in which the heart cannot pump enough blood to supply the body. The main questions this study aims to answer are:
Does norepinephrine reduce the risk of death or worsening cardiogenic shock compared with dopamine?
Does norepinephrine lead to fewer complications such as arrhythmias, the need for mechanical circulatory support, or cardiac arrest?
Researchers will compare norepinephrine and dopamine to see which drug better stabilizes blood pressure, improves tissue perfusion, and prevents progression of shock during the early phase of treatment.
Participants will:
Be randomly assigned to receive either norepinephrine or dopamine as the first vasoactive drug
Receive treatment and monitoring based on current clinical guidelines for cardiogenic shock
Undergo regular assessments of blood pressure, laboratory values, heart rhythm, and organ function during hospitalization
Be followed for outcomes at 1 month, 6 months, and 1 year after enrollment
This study aims to provide evidence that will help determine which initial vasoactive drug offers better outcomes for patients with cardiogenic shock and guide future treatment recommendations.
Eligibility criteria
Qualifiers
Age ≥ 19
Cardiogenic shocka in the stage of Society for cardiovascular angiography and intervention (SCAI) C or D
Cardiogenic shock was defined as follows, and should fulfill both 1) and 2)
systolic blood pressure <90 mm Hg for ≥30 min or need of inotropes or vasopressors to maintain systolic blood pressure >90 mm Hg And
Disqualifiers
Administration of vasoactive drug more than 6 hours before enrollment
Patients already on temporary mechanical circulatory supportb before enrollment
Glasgow Coma Scale lower than 8 or other evidence of irreversible brain injury
Shock etiologies other than cardiogenic which include postcardiotomy shock or mixed shock
Trial design
Treatments tested in this trial
- Norepinephrine
- Dopamine Agent