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

28 de abril de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

512

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Min Chul Kim, Professor, MD, PhD
  • Número de telefone: 82-10-4606-2643
  • E-mail: kmc3242@hanmail.net

Estude backup de contato

  • Nome: Yongwhan Lim, Professor, MD
  • Número de telefone: 82-10-3229-3392
  • E-mail: kalmiarmfl@naver.com

Locais de estudo

  • Coréia do Sul
      • Gwangju, Coréia do Sul, 61469
        • Chonnam National University Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: 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.
Comparador Ativo: 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.
Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
A composite of 28-day all-cause death or signs of progressive or refractory cardiogenic shock within the first 24 hours
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
All-cause death at 28th day
Prazo: 28 days
28 days
Cardiovascular death at 28th day
Prazo: 28 days
28 days
Number of participants who develop signs of progressive or refractory cardiogenic shock within the first 24 hours
Prazo: 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
Prazo: 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
Prazo: the first 24 hours
the first 24 hours
Number of participants with cardiac arrest requiring cardiopulmonary resuscitation within the first 24 hours
Prazo: the first 24 hours
the first 24 hours
Number of participants with arrhythmia requiring electrical cardioversion within the first 24 hours
Prazo: 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
Prazo: 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
Prazo: First 28 days
First 28 days
Duration of vasoactive drug use (hours) during initial hospitalization
Prazo: 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
Prazo: First 28 days
First 28 days
Number of participants who develop acute limb ischemia requiring surgical or interventional treatment during initial hospitalization
Prazo: First 28 days
First 28 days
Number of participants who develop ischemic or hemorrhagic stroke during initial hospitalization
Prazo: First 28 days
First 28 days
All-cause death at 1 year
Prazo: 1 year
1 year
Cardiovascular death at 1 year
Prazo: 1 year
1 year
Number of participants with rehospitalization due to heart failure within 1 year
Prazo: 1 year
1 year
Number of participants with first-time initiation of renal replacement therapy at 1 year
Prazo: 1 year
1 year

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Chonnam National University Hospital

Investigadores

  • Investigador principal: Min Chul Kim, Professor, MD, PhD, Chonnam National University Hospital
  • Cadeira de estudo: Min Chul Kin, Professor, MD, PhD, Chonnam National University Hospital

Publicações e links úteis

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Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

31 de maio de 2026

Conclusão Primária (Estimado)

31 de maio de 2031

Conclusão do estudo (Estimado)

31 de maio de 2032

Datas de inscrição no estudo

Enviado pela primeira vez

22 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de abril de 2026

Primeira postagem (Real)

1 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CNUH-2026-098

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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