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.
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
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
Parallel
Norepinephrine
DrugNorepinephrine will be administered as an intravenous continuous infusion and used as the first-line vasoactive drug for the treatment of cardiogenic shock. The medication will be prepared in standard intensive care unit infusion bags and delivered through a controlled infusion pump. The infusion will be initiated and titrated according to a protocol-defined dosing algorithm, with adjustments based on blood pressure, hemodynamic response, laboratory values, and overall clinical assessment. If a participant was receiving vasoactive agents before randomization, norepinephrine will be started at an equivalent protocol-defined dose, and non-assigned agents will be tapered as clinically appropriate. The duration of infusion will depend on the participant's clinical stabilization. All administration and monitoring will follow current clinical guidelines for cardiogenic shock.
Dopamine Agent
DrugDopamine will be administered as an intravenous continuous infusion and used as the first-line vasoactive drug for the treatment of cardiogenic shock. The medication will be prepared in standard intensive care unit infusion bags and delivered through a controlled infusion pump. The infusion will be initiated and titrated according to a protocol-defined dosing algorithm, with adjustments based on blood pressure, hemodynamic response, laboratory values, and overall clinical assessment. If a participant was receiving vasoactive agents before randomization, dopamine will be started at an equivalent protocol-defined dose, and non-assigned agents will be tapered as clinically appropriate. The duration of infusion will depend on the participant's clinical stabilization. All administration and monitoring will follow current clinical guidelines for cardiogenic shock.
A composite of 28-day all-cause death or signs of progressive or refractory cardiogenic shock within the first 24 hours
signs of progressive or refractory cardiogenic shock within the first 24 hours, defined as follows, any of: * Sustained low blood pressure (mean arterial pressure \< 60mmHg) more than 30 minutes * Lactate over 4 mmol/L, higher than initial lactate level at 6 hours after randomization * Initiation of treatment with mechanical circulatory support * Initiation of second-line vasoactive drug * Cardiac arrest requiring cardiopulmonary resuscitation * Arrhythmia requiring electrical cardioversion \*\*For patients who experience more than one qualifying event, the primary endpoint will be determined based on the first event that occurs.
All-cause death at 28th day
Cardiovascular death at 28th day
Number of participants who develop signs of progressive or refractory cardiogenic shock within the first 24 hours
defined as follows, any of: * Sustained low blood pressure (mean arterial pressure \< 60mmHg) more than 30 minutes * Lactate over 4 mmol/L, higher than initial lactate level at 6 hours after randomization * Initiation of treatment with mechanical circulatory support * Initiation of second-line vasoactive drug * Cardiac arrest requiring cardiopulmonary resuscitation * Arrhythmia requiring electrical cardioversion
Number of participants who initiate mechanical circulatory support within the first 24 hours
Impella, ECMO or IABP
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