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Study Comparing Norepinephrine and Dobutamine for Patients with Cardiogenic Shock

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of two medications, norepinephrine and dobutamine, in patients experiencing cardiogenic shock. Cardiogenic shock is a serious condition where the heart suddenly can't pump enough blood to meet the body's needs. The study aims to compare how these medications affect the levels of a substance called lactate in the blood, which can indicate how well the body is responding to treatment.

Participants in the study will receive either norepinephrine alone or a combination of norepinephrine and dobutamine. Both medications are given through an infusion, which means they are delivered directly into the bloodstream. The study will monitor changes in blood lactate levels over a period of 72 hours to see which treatment is more effective. In addition to lactate levels, the study will also look at other outcomes, such as the need for additional medical support and changes in a health score called the SOFA score, which helps assess the severity of a patient's condition.

The purpose of this study is to better understand which treatment option may be more beneficial for patients with cardiogenic shock. By comparing the effects of norepinephrine and dobutamine, researchers hope to find the most effective way to support the heart and improve patient outcomes during this critical condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria: experiencing cardiogenic shock with low blood pressure, being over 18 years old, and providing written consent.

    Enrollment occurs within 3 hours of the acute event.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: one receiving norepinephrine alone, and the other receiving dobutamine plus norepinephrine.

    This process ensures unbiased distribution of treatments.

  3. Step 3

    Treatment administration

    Both medications are administered through infusion, which involves delivering the drug directly into the bloodstream.

    The treatment aims to stabilize blood pressure and improve heart function.

  4. Step 4

    Monitoring and assessment

    Blood lactate levels are measured at the start (0-1 hours after randomization) and again at 72 hours to assess changes.

    In the event of death, the last available lactate value is used for comparison.

  5. Step 5

    Evaluation of outcomes

    Primary outcomes include changes in blood lactate concentration over the first 72 hours.

    Secondary outcomes involve survival rates, the need for additional support devices, and changes in the SOFA score, which evaluates organ function.

  6. Step 6

    Completion of participation

    Participation concludes after the final assessments, which may occur at discharge or after 7 days, depending on the individual's condition.

    The study is expected to end by June 30, 2026.

Who can join the trial?

7 criteria

  • The patient must have **cardiogenic shock**. This is a condition where the heart suddenly can't pump enough blood to meet the body's needs.
  • The patient must have a **systolic systemic arterial pressure (SBP)** of less than 90 mmHg or a **mean arterial pressure (MAP)** of less than 60 mmHg for at least 30 consecutive minutes. These are measurements of blood pressure.
  • The patient must need **pharmacological support**. This means they need medication, like inotropes or vasopressors, to keep their SBP above 90 mmHg or MAP above 60 mmHg.
  • The patient must be over 18 years old.
  • The patient must be enrolled in the study within 3 hours of the acute event, which is the sudden onset of the condition.
  • The patient must provide **written informed consent**. This means they agree to participate in the study after being informed about it.
  • The patient must have a **SOFA score** of less than 2. The SOFA score is a way to track a person's status during a stay in an intensive care unit, based on different measurements.

Who cannot join the trial?

1 criterion

  • Patients who are experiencing cardiogenic shock cannot participate. This is a condition where the heart suddenly can't pump enough blood to meet the body's needs.
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Investigated drugs

  • Norepinephrine

    is a medication used to increase blood pressure and improve blood flow in patients experiencing severe heart problems, such as cardiogenic shock. It works by narrowing the blood vessels, which helps to raise blood pressure and improve the heart's ability to pump blood.

  • Dobutamine

    is a medication that helps the heart pump more effectively. It is often used in patients with heart failure or cardiogenic shock to improve heart function. Dobutamine works by stimulating the heart muscle, increasing the strength of the heart's contractions, and improving blood flow to the body.

What is already known about the treatment

  • Norepinephrine

    Norepinephrine is administered intravenously and is used in the treatment of cardiogenic shock. It is currently well-established in medical practice and literature as a critical medication for managing low blood pressure in shock conditions. The main therapeutic indication for norepinephrine is to increase blood pressure in acute situations. At the molecular level, it works by stimulating alpha-adrenergic receptors, leading to vasoconstriction and increased blood pressure. It is classified as a vasopressor.

  • Dobutamine

    Dobutamine is also administered intravenously and is used in combination with norepinephrine for treating cardiogenic shock. It is recognized in medical literature as a medication that helps improve heart function in acute heart failure. The primary therapeutic indication for dobutamine is to enhance cardiac output. Its mechanism of action involves stimulating beta-1 adrenergic receptors, which increases heart contractility and output. It is classified as an inotropic agent.

Investigated diseases

Cardiogenic shock – Cardiogenic shock is a serious condition where the heart suddenly cannot pump enough blood to meet the body's needs. It often occurs after a severe heart attack, but can also result from other heart problems. As the heart's pumping ability decreases, blood pressure drops, leading to reduced blood flow to vital organs. This can cause symptoms like rapid breathing, severe shortness of breath, and confusion. The condition can progress quickly, requiring immediate medical attention to support heart function and blood circulation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520399-84-00Estimated enrolment46 patientsSponsorAzienda Unita' Sanitaria Locale Toscana Sud Est

sourced from the EU Clinical Trials Register and site verification

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