Assessing Catecholamine Treatment Initiation Options: Norepinephrine vs Dopamine for Cardiogenic Shock

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorChonnam National University Hospital

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

Treatment groups

512 Participants
are divided into 2 treatment groups