Norepinephrine vs Dopamine as the First Vasoactive Drug in Cardiogenic Shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label randomized trial compares norepinephrine to dopamine as the initial vasoactive therapy in adults with cardiogenic shock. Participants are assigned to receive one of the two drugs according to a protocol-defined dosing algorithm and receive standard care across centers. The study aims to determine which agent better stabilizes blood pressure and tissue perfusion while minimizing complications such as arrhythmias or the need for mechanical circulatory support. Primary outcomes focus on death or progression of shock, with secondary considerations on safety and hemodynamic improvement. The trial is conducted at Chonnam National University Hospital and reflects contemporary management practices for cardiogenic shock.

Why it matters

Who can join: the full rules

Inclusion Criteria: 1\&2

1. Age ≥ 19
2. 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)

     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

        a Cardiogenic shock was defined as follows, and should fulfill both 1) and 2)

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     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
   * 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

Exclusion Criteria: any of these,

1. Administration of vasoactive drug more than 6 hours before enrollment
2. Receiving norepinephrine or dopamine at doses exceeding the protocol defined maximal dose at the time of enrollment.
3. Receiving any vasoactive agent other than norepinephrine or dopamine
4. Patients receiving a continuous infusion of both norepinephrine and dopamine
5. Patients already on temporary mechanical circulatory supportb before enrollment
6. Cardiogenic shock in the stage of SCAI E
7. Glasgow Coma Scale lower than 8 or other evidence of irreversible brain injury
8. Shock etiologies other than cardiogenic which include postcardiotomy shock or mixed shock
9. Pregnancy or lactation

Where it's running

• Chonnam National University Hospital
  Gwangju, Jeollanam-do, South Korea Recruiting

Study contacts

• Principal investigator: Min Chul Kim, Professor, MD, PhD — Chonnam National University Hospital
• Study coordinator: Min Chul Kim, Professor, MD, PhD
• Email: kmc3242@hanmail.net
• Phone: 820622204770

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.