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

28. april 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

512

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Min Chul Kim, Professor, MD, PhD
  • Telefonnummer: 82-10-4606-2643
  • E-post: kmc3242@hanmail.net

Studer Kontakt Backup

Studiesteder

  • Sør -Korea
      • Gwangju, Sør -Korea, 61469
        • Chonnam National University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Aktiv komparator: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
A composite of 28-day all-cause death or signs of progressive or refractory cardiogenic shock within the first 24 hours
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chonnam National University Hospital

Etterforskere

  • Hovedetterforsker: Min Chul Kim, Professor, MD, PhD, Chonnam National University Hospital
  • Studiestol: Min Chul Kin, Professor, MD, PhD, Chonnam National University Hospital

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

31. mai 2026

Primær fullføring (Antatt)

31. mai 2031

Studiet fullført (Antatt)

31. mai 2032

Datoer for studieregistrering

Først innsendt

22. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

1. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CNUH-2026-098

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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