Cardiogenic ShockACTION-CSNCT07562932
Assessing Catecholamine Treatment Initiation Options: Norepinephrine vs Dopamine for Cardiogenic Shock
A study testing Norepinephrine and Dopamine Agent in people with Cardiogenic Shock, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Norepinephrine and Dopamine Agent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jun 2026to 31 May 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19
- Cardiogenic shock (a) in the stage of Society for cardiovascular angiography and intervention (SCAI) C or D
- Cardiogenic shock (a) 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
- Impaired cardiac function confirmed by cardiac catheterization or echocardiography
- a Cardiogenic shock was defined as follows, and should fulfill both 1) and 2)
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- systolic blood pressure <90 mm Hg for ≥30 min or need of inotropes or vasopressors to maintain systolic blood pressure >90 mm Hg And
- Impaired cardiac function confirmed by cardiac catheterization or echocardiography
- Cardiac index (CI) < 2.2 L/min/m², measured by pulmonary artery catheter
- Left ventricular ejection fraction LVEF < 45% on echocardiography;
- Right ventricular dysfunction, defined by one or more of: TAPSE < 17 mm; S' < 9.5 cm/sec; FAC < 35%11; or visual estimation of RV wall motion abnormality.
- Or Structural cardiac abnormality capable of causing cardiogenic shock, even if LV/RV systolic indices do not meet the thresholds above (examples, infarct ventricular septal rupture or severe valvular regurgitation)
- Patients will be further classified based on the SCAI shock classification system12 as follows:
- SCAI B: no signs of hypoperfusion
- 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
- SCAI D: shock progression despite use of the index vasoactive agent at ≥75% of the predefined maximal dose
- SCAI E: Impending arrest or overt circulatory collapse
Who cannot join
- Administration of vasoactive drug more than 6 hours before enrollment
- Receiving norepinephrine or dopamine at doses exceeding the protocol defined maximal dose at the time of enrollment.
- Receiving any vasoactive agent other than norepinephrine or dopamine
- Patients receiving a continuous infusion of both norepinephrine and dopamine
- Patients already on temporary mechanical circulatory supportb before enrollment
- Cardiogenic shock in the stage of SCAI E
Show all 9Show fewer
- 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
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chonnam National University Hospital
Gwangju, Jeollanam-do, 61469
Yongwhan Lim, M.D, +820622204770, kalmiarmfl@naver.com
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Cardiogenic Shock
- Being tested
- Norepinephrine, Dopamine Agent
- Keywords
- Vasoactive drug, Norepinephrine, Dopamine, Randomized controlled trial, Cardiogenic shock
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
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.
Dopamine AgentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine First-Line Vasoactive Drug | Experimental | 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. Receives: Drug: Norepinephrine |
| Dopamine First-Line Vasoactive Drug | Active comparator | 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. Receives: Drug: Dopamine Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 4 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.
Measured: 28 days
Secondary outcomes (17)
All-cause death at 28th day
Measured: 28 days
Cardiovascular death at 28th day
Measured: 28 days
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 4 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
Measured: the first 24 hours
Number of participants who initiate mechanical circulatory support within the first 24 hours
Impella, ECMO or IABP
Measured: the first 24 hours
Number of participants who initiate a second-line vasoactive drug within the first 24 hours
Measured: the first 24 hours
Number of participants with cardiac arrest requiring cardiopulmonary resuscitation within the first 24 hours
Measured: the first 24 hours
Number of participants with arrhythmia requiring electrical cardioversion within the first 24 hours
Measured: 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
Temporary mechanical circulatory support include Impella, ECMO or IABP.
Measured: First 28 days
Number of participants with first-time initiation of renal replacement therapy for acute kidney injury (AKI) during initial hospitalization
Measured: First 28 days
Duration of vasoactive drug use (hours) during initial hospitalization
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.
Measured: First 28 days
Number of participants with new-onset or recurrent atrial or ventricular arrhythmia requiring pharmacologic or electrical cardioversion during initial hospitalization
Measured: First 28 days
Number of participants who develop acute limb ischemia requiring surgical or interventional treatment during initial hospitalization
Measured: First 28 days
Number of participants who develop ischemic or hemorrhagic stroke during initial hospitalization
Measured: First 28 days
All-cause death at 1 year
Measured: 1 year
Cardiovascular death at 1 year
Measured: 1 year
Number of participants with rehospitalization due to heart failure within 1 year
Measured: 1 year
Number of participants with first-time initiation of renal replacement therapy at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start16 Jun 2026
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Chul Kim, Chonnam National University Hospital
- Investigators
- Min Chul Kim, Professor, MD, PhD, Principal investigator, Chonnam National University HospitalMin Chul Kin, Professor, MD, PhD, Study chair, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562932
- Sponsor's protocol ID
- CNUH-2026-098
- Acronym
- ACTION-CS
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
PubMed 34447992Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
PubMed 30571511Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
PubMed 22890468Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.
PubMed 28183511Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
PubMed 29891620Mathew R, Di Santo P, Hibbert B. Milrinone as Compared with Dobutamine in the Treatment of Cardiogenic Shock. Reply. N Engl J Med. 2021 Nov 25;385(22):2108-2109. doi: 10.1056/NEJMc2114890. No abstract available.
PubMed 34818495Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.
PubMed 36017572Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.
PubMed 39210723Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
PubMed 37622654Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.
PubMed 40014670Gaies MG, Gurney JG, Yen AH, Napoli ML, Gajarski RJ, Ohye RG, Charpie JR, Hirsch JC. Vasoactive-inotropic score as a predictor of morbidity and mortality in infants after cardiopulmonary bypass. Pediatr Crit Care Med. 2010 Mar;11(2):234-8. doi: 10.1097/PCC.0b013e3181b806fc.
PubMed 19794327Naidu SS, Baran DA, Jentzer JC, Hollenberg SM, van Diepen S, Basir MB, Grines CL, Diercks DB, Hall S, Kapur NK, Kent W, Rao SV, Samsky MD, Thiele H, Truesdell AG, Henry TD. SCAI SHOCK Stage Classification Expert Consensus Update: A Review and Incorporation of Validation Studies: This statement was endorsed by the American College of Cardiology (ACC), American College of Emergency Physicians (ACEP), American Heart Association (AHA), European Society of Cardiology (ESC) Association for Acute Cardiovascular Care (ACVC), International Society for Heart and Lung Transplantation (ISHLT), Society of Critical Care Medicine (SCCM), and Society of Thoracic Surgeons (STS) in December 2021. J Soc Cardiovasc Angiogr Interv. 2022 Jan 30;1(1):100008. doi: 10.1016/j.jscai.2021.100008. eCollection 2022 Jan-Feb. No abstract available.
PubMed 39130139Na SJ, Yang JH, Ko RE, Chung CR, Cho YH, Choi KH, Kim D, Park TK, Lee JM, Song YB, Choi JO, Hahn JY, Choi SH, Gwon HC. Dopamine versus norepinephrine as the first-line vasopressor in the treatment of cardiogenic shock. PLoS One. 2022 Nov 3;17(11):e0277087. doi: 10.1371/journal.pone.0277087. eCollection 2022.
PubMed 36327286De Backer D, Biston P, Devriendt J, Madl C, Chochrad D, Aldecoa C, Brasseur A, Defrance P, Gottignies P, Vincent JL; SOAP II Investigators. Comparison of dopamine and norepinephrine in the treatment of shock. N Engl J Med. 2010 Mar 4;362(9):779-89. doi: 10.1056/NEJMoa0907118.
PubMed 20200382Sinha SS, Morrow DA, Kapur NK, Kataria R, Roswell RO. 2025 Concise Clinical Guidance: An ACC Expert Consensus Statement on the Evaluation and Management of Cardiogenic Shock: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2025 Apr 29;85(16):1618-1641. doi: 10.1016/j.jacc.2025.02.018. Epub 2025 Mar 17. No abstract available.
PubMed 40100174
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Catecholamine Treatment Initiation Options: Norepinephrine vs Dopamine for Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT07562932
- Acronym / sponsor ID
- ACTION-CS / CNUH-2026-098
- Conditions
- Cardiogenic Shock
- Keywords
- Vasoactive drug, Norepinephrine, Dopamine, Randomized controlled trial, Cardiogenic shock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2032 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine First-Line Vasoactive Drug | Experimental | Drug: NorepinephrineParticipants 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. |
| Dopamine First-Line Vasoactive Drug | Active comparator | Drug: Dopamine Agentarticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 19
- Cardiogenic shock (a) in the stage of Society for cardiovascular angiography and intervention (SCAI) C or D
- a Cardiogenic shock was defined as follows, and should fulfill both 1) and 2)
- <!-- -->
- Or Structural cardiac abnormality capable of causing cardiogenic shock, even if LV/RV systolic indices do not meet the thresholds above (examples, infarct ventricular septal rupture or severe valvular regurgitation)
Key exclusion criteria (9 listed)
- Administration of vasoactive drug more than 6 hours before enrollment
- Receiving norepinephrine or dopamine at doses exceeding the protocol defined maximal dose at the time of enrollment.
- Receiving any vasoactive agent other than norepinephrine or dopamine
- Patients receiving a continuous infusion of both norepinephrine and dopamine
- Patients already on temporary mechanical circulatory supportb before enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorepinephrineNorepinephrine 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. | Drug | Norepinephrine First-Line Vasoactive Drug |
| Dopamine AgentDopamine 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. | Drug | Dopamine First-Line Vasoactive Drug |
Primary outcome
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 4 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.
17 secondary outcomes
All-cause death at 28th day
Time frame: 28 days
Cardiovascular death at 28th day
Time frame: 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
Number of participants who initiate mechanical circulatory support within the first 24 hours
Time frame: 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
Number of participants with cardiac arrest requiring cardiopulmonary resuscitation within the first 24 hours
Time frame: the first 24 hours
Number of participants with arrhythmia requiring electrical cardioversion within the first 24 hours
Time frame: 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
Number of participants with first-time initiation of renal replacement therapy for acute kidney injury (AKI) during initial hospitalization
Time frame: First 28 days
Duration of vasoactive drug use (hours) during initial hospitalization
Time frame: 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
Number of participants who develop acute limb ischemia requiring surgical or interventional treatment during initial hospitalization
Time frame: First 28 days
Number of participants who develop ischemic or hemorrhagic stroke during initial hospitalization
Time frame: First 28 days
All-cause death at 1 year
Time frame: 1 year
Cardiovascular death at 1 year
Time frame: 1 year
Number of participants with rehospitalization due to heart failure within 1 year
Time frame: 1 year
Number of participants with first-time initiation of renal replacement therapy at 1 year
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 34447992McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Background: PubMed 30571511Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
- Background: PubMed 22890468Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
- Background: PubMed 28183511Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.
- Background: PubMed 29891620Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
- Background: PubMed 34818495Mathew R, Di Santo P, Hibbert B. Milrinone as Compared with Dobutamine in the Treatment of Cardiogenic Shock. Reply. N Engl J Med. 2021 Nov 25;385(22):2108-2109. doi: 10.1056/NEJMc2114890. No abstract available.
- Background: PubMed 36017572Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.
- Background: PubMed 39210723Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.
- Background: PubMed 37622654Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
- Background: PubMed 40014670Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.
- Background: PubMed 19794327Gaies MG, Gurney JG, Yen AH, Napoli ML, Gajarski RJ, Ohye RG, Charpie JR, Hirsch JC. Vasoactive-inotropic score as a predictor of morbidity and mortality in infants after cardiopulmonary bypass. Pediatr Crit Care Med. 2010 Mar;11(2):234-8. doi: 10.1097/PCC.0b013e3181b806fc.
- Background: PubMed 39130139Naidu SS, Baran DA, Jentzer JC, Hollenberg SM, van Diepen S, Basir MB, Grines CL, Diercks DB, Hall S, Kapur NK, Kent W, Rao SV, Samsky MD, Thiele H, Truesdell AG, Henry TD. SCAI SHOCK Stage Classification Expert Consensus Update: A Review and Incorporation of Validation Studies: This statement was endorsed by the American College of Cardiology (ACC), American College of Emergency Physicians (ACEP), American Heart Association (AHA), European Society of Cardiology (ESC) Association for Acute Cardiovascular Care (ACVC), International Society for Heart and Lung Transplantation (ISHLT), Society of Critical Care Medicine (SCCM), and Society of Thoracic Surgeons (STS) in December 2021. J Soc Cardiovasc Angiogr Interv. 2022 Jan 30;1(1):100008. doi: 10.1016/j.jscai.2021.100008. eCollection 2022 Jan-Feb. No abstract available.
- eCRFLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Chul Kim, Professor, MD, PhD principal investigator
Chonnam National University Hospital
Min Chul Kin, Professor, MD, PhD study chair
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine and Dopamine Agent in people with Cardiogenic Shock, run by Chonnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Chul Kim, Professor, MD, PhD (820622204770, kmc3242@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07562932, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.