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

NCT07562932 | Not Yet Recruiting DMC

• 1 other identifier: CNUH-2026-098
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiogenic Shock

Keywords

Vasoactive drug; Norepinephrine; Dopamine; Randomized controlled trial; Cardiogenic shock

Outcome Measures

Primary Outcomes (1)

• 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 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 Outcomes (17)

• All-cause death at 28th day

  28 days

• Cardiovascular death at 28th day

  28 days

• Number of participants who develop signs of progressive or refractory cardiogenic shock within the first 24 hours

  the first 24 hours

• Number of participants who initiate mechanical circulatory support within the first 24 hours

  the first 24 hours

• Number of participants who initiate a second-line vasoactive drug within the first 24 hours

  the first 24 hours

Study Arms (2)

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.

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.

Drug: Dopamine Agent

Interventions

Norepinephrine DRUG

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.

Norepinephrine First-Line Vasoactive Drug

Dopamine Agent DRUG

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.

Dopamine First-Line Vasoactive Drug

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19
• Cardiogenic shocka in the stage of Society for cardiovascular angiography and intervention (SCAI) C or D
• Cardiogenic shock was defined as follows, and should fulfill both 1) and 2)
• systolic blood pressure \<90 mm Hg for ≥30 min or need of inotropes or vasopressors to maintain systolic blood pressure \>90 mm Hg And
• Impaired cardiac function confirmed by cardiac catheterization or echocardiography
• Patients will be further classified based on the SCAI shock classification system 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: requirement of second-line vasoactive drug or mechanical circulatory support based on the predefined treatment protocol

You may not qualify if:

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

Sponsors & Collaborators

• Chonnam National University Hospital: lead

Study Sites (1)

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

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Related Links

• eCRF

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Min Chul Kim, Professor, MD, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Min Chul Kin, Professor, MD, PhD

  Chonnam National University Hospital

  STUDY CHAIR

Central Study Contacts

Min Chul Kim, Professor, MD, PhD

CONTACT

82-10-4606-2643; kmc3242@hanmail.net

Yongwhan Lim, Professor, MD

CONTACT

82-10-3229-3392; kalmiarmfl@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): May 31, 2032
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)