Assessing Catecholamine Treatment Initiation Options: Norepinephrine vs Dopamine for Cardiogenic Shock (ACTION-CS)

April 28, 2026 updated by: Min Chul Kim, Chonnam National University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiogenic shock is a severe form of acute circulatory failure characterized by inadequate cardiac output, tissue hypoperfusion, and high short-term mortality. Despite advances in revascularization, mechanical circulatory support, and critical care management, early hemodynamic stabilization remains a major determinant of clinical outcomes. Vasoactive drugs are essential components of initial therapy, yet the optimal first-line agent for cardiogenic shock has not been definitively established.

Norepinephrine and dopamine are widely used vasoactive agents, but they may exert their effects through different physiological mechanisms. Their relative impact on vascular tone, cardiac output, and heart rate can vary depending on dose, patient characteristics, and the underlying pathophysiology of shock. Prior studies, including observational analyses and a landmark randomized trial, have suggested potential differences in safety profiles-particularly regarding arrhythmias-but these findings have not been confirmed in a contemporary population with standardized shock definitions and modern management strategies.

This multicenter, open-label, randomized clinical trial is designed to compare norepinephrine and dopamine as the initial vasoactive drug in adults with cardiogenic shock. The study uses a protocol-defined dosing algorithm to ensure consistent titration and incorporates current guideline-based management across participating centers. The primary endpoint evaluates both early hemodynamic deterioration and 28-day mortality, reflecting clinically meaningful outcomes during the most vulnerable phase of shock.

By enrolling a large, diverse population across multiple centers, this trial aims to provide definitive evidence regarding the comparative effectiveness and safety of norepinephrine versus dopamine as first-line therapy. The results are expected to inform clinical guidelines and support standardized treatment strategies for patients with cardiogenic shock.

Study Type

Interventional

Enrollment (Estimated)

512

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Min Chul Kim, Professor, MD, PhD
  • Phone Number: 82-10-4606-2643
  • Email: kmc3242@hanmail.net

Study Contact Backup

Study Locations

  • South Korea
      • Gwangju, South Korea, 61469
        • Chonnam National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: 1&2

  1. Age ≥ 19

  2. 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)

      1. systolic blood pressure <90 mm Hg for ≥30 min or need of inotropes or vasopressors to maintain systolic blood pressure >90 mm Hg And
      2. Impaired cardiac function confirmed by cardiac catheterization or echocardiography

    • Patients will be further classified based on the SCAI shock classification system as follows:

      1. SCAI B: no signs of hypoperfusion
      2. SCAI C: any signs of hypoperfusion, cardiogenic shock will be classified as SCAI C, and these include mental status change, cool and clammy skin, mottled skin appearance, decreased urine output (30ml/hour) or lactate over 2.0mmol/L
      3. SCAI D: requirement of second-line vasoactive drug or mechanical circulatory support based on the predefined treatment protocol

Exclusion Criteria: any of these,

  1. Administration of vasoactive drug more than 6 hours before enrollment
  2. Patients already on temporary mechanical circulatory supportb before enrollment
  3. Glasgow Coma Scale lower than 8 or other evidence of irreversible brain injury
  4. Shock etiologies other than cardiogenic which include postcardiotomy shock or mixed shock
  5. Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Norepinephrine First-Line Vasoactive Drug
Participants assigned to this arm will receive norepinephrine as the first-line vasoactive drug for the treatment of cardiogenic shock. The drug will be initiated and titrated according to the protocol-defined dosing algorithm, with adjustments based on hemodynamic response, laboratory values, and clinical status. If participants were receiving vasoactive agents before randomization, norepinephrine will be started at an equivalent protocol-defined dose, and other agents will be tapered as clinically appropriate. All treatment and monitoring will follow current clinical guidelines for cardiogenic shock.
Drug: Norepinephrine
Norepinephrine 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.
Active Comparator: Dopamine First-Line Vasoactive Drug
articipants assigned to this arm will receive dopamine as the first-line vasoactive drug for the treatment of cardiogenic shock. The drug will be initiated and titrated according to the protocol-defined dosing algorithm, with adjustments based on hemodynamic response, laboratory values, and clinical status. If participants were receiving vasoactive agents before randomization, dopamine will be started at an equivalent protocol-defined dose, and other agents will be tapered as clinically appropriate. All treatment and monitoring will follow current clinical guidelines for cardiogenic shock.
Drug: Dopamine Agent
Dopamine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A composite of 28-day all-cause death or signs of progressive or refractory cardiogenic shock within the first 24 hours
Time Frame: 28 days

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.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death at 28th day
Time Frame: 28 days
28 days
Cardiovascular death at 28th day
Time Frame: 28 days
28 days
Number of participants who develop signs of progressive or refractory cardiogenic shock within the first 24 hours
Time Frame: 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
the first 24 hours
Number of participants who initiate mechanical circulatory support within the first 24 hours
Time Frame: the first 24 hours
Impella, ECMO or IABP
the first 24 hours
Number of participants who initiate a second-line vasoactive drug within the first 24 hours
Time Frame: the first 24 hours
the first 24 hours
Number of participants with cardiac arrest requiring cardiopulmonary resuscitation within the first 24 hours
Time Frame: the first 24 hours
the first 24 hours
Number of participants with arrhythmia requiring electrical cardioversion within the first 24 hours
Time Frame: the first 24 hours
the first 24 hours
Number of participants who receive cardiac replacement treatment (temporary or durable mechanical circulatory support or heart transplantation) within the first 28 days
Time Frame: First 28 days
Temporary mechanical circulatory support include Impella, ECMO or IABP.
First 28 days
Number of participants with first-time initiation of renal replacement therapy for acute kidney injury (AKI) during initial hospitalization
Time Frame: First 28 days
First 28 days
Duration of vasoactive drug use (hours) during initial hospitalization
Time Frame: First 28 days
Discontinuation of vasoactive drugs is defined as the point when they are no longer required for more than 24 hours and there is no recurrence of shock.
First 28 days
Number of participants with new-onset or recurrent atrial or ventricular arrhythmia requiring pharmacologic or electrical cardioversion during initial hospitalization
Time Frame: First 28 days
First 28 days
Number of participants who develop acute limb ischemia requiring surgical or interventional treatment during initial hospitalization
Time Frame: First 28 days
First 28 days
Number of participants who develop ischemic or hemorrhagic stroke during initial hospitalization
Time Frame: First 28 days
First 28 days
All-cause death at 1 year
Time Frame: 1 year
1 year
Cardiovascular death at 1 year
Time Frame: 1 year
1 year
Number of participants with rehospitalization due to heart failure within 1 year
Time Frame: 1 year
1 year
Number of participants with first-time initiation of renal replacement therapy at 1 year
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonnam National University Hospital

Investigators

  • Principal Investigator: Min Chul Kim, Professor, MD, PhD, Chonnam National University Hospital
  • Study Chair: Min Chul Kin, Professor, MD, PhD, Chonnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 31, 2026

Primary Completion (Estimated)

May 31, 2031

Study Completion (Estimated)

May 31, 2032

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNUH-2026-098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

ndividual participant data (IPD) will not be shared because of privacy considerations, regulatory requirements, and institutional policies governing the handling of sensitive clinical information. The study involves critically ill patients with cardiogenic shock, and sharing detailed participant-level data may pose risks to confidentiality. Only aggregated study results will be made publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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