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Study on the Effects of Levosimendan for Patients with Cardiogenic Shock Being Weaned from ECMO

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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 a medication called Levosimendan in patients who are being weaned off a life-support machine known as venoarterial extracorporeal membrane oxygenation (ECMO). The study is particularly interested in patients experiencing a severe heart condition called cardiogenic shock, where the heart suddenly can't pump enough blood to meet the body's needs. The purpose of the study is to see if Levosimendan can help improve heart function and blood flow, making it easier for patients to come off ECMO support.

During the study, participants will receive Levosimendan through an infusion, which is a way of delivering medication directly into the bloodstream. The study will compare the effects of Levosimendan with those of a placebo. Researchers will monitor changes in heart function and blood flow over a period of time, using a technique called Doppler echocardiography, which is a type of ultrasound that shows how blood flows through the heart. The study will also look at other factors, such as changes in blood pressure and overall survival rates.

The trial will last for a specific period, during which participants will be closely observed to gather data on how well Levosimendan works in improving heart function and aiding in the removal of ECMO support. The results of this study could provide valuable insights into the potential benefits of Levosimendan for patients with cardiogenic shock who are undergoing ECMO treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, eligibility is confirmed based on age (18 years or older) and current treatment with ECMO for cardiogenic shock or refractory cardiac arrest.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes measuring the left ventricular outflow tract velocity time integral using Doppler echocardiography.

  3. Step 3

    Medication administration

    The trial involves the administration of Levosimendan, a medication given as a solution for infusion. The dosage is 2.5 mg/ml, and it is administered to improve cardiac output and pulsatile flow.

  4. Step 4

    Monitoring period

    The primary outcome is monitored by measuring changes in the left ventricular outflow tract velocity time integral from baseline to 72 hours after the initiation of ECMO or before ECMO support is stopped, whichever occurs first.

    Secondary outcomes include changes in pulse pressure, ECMO weaning success, mortality rates, urinary output, and central venous saturation at specified intervals post-ECMO cessation.

  5. Step 5

    Completion of trial

    The trial is expected to conclude by January 1, 2025. The duration of participation may vary depending on individual response and the timing of ECMO weaning.

Who can join the trial?

4 criteria

  • Must be **18 years old** or older.
  • Currently receiving **ECMO** treatment. ECMO stands for **Extracorporeal Membrane Oxygenation**, which is a machine that helps the heart and lungs work better when they are not functioning well.
  • Experiencing **cardiogenic shock**. This is a condition where the heart suddenly can't pump enough blood to meet the body's needs.
  • May also be experiencing **refractory cardiac arrest**, which means the heart has stopped beating and is not responding to standard treatments.

Who cannot join the trial?

4 criteria

  • Patients with cardiogenic shock cannot participate. Cardiogenic shock is a condition where the heart suddenly can't pump enough blood to meet the body's needs.
  • Patients who are not within the specified age range cannot participate. The trial is for certain age groups only.
  • Patients who do not fit into the specified clinical trial groups cannot participate. This means the trial is looking for people with specific characteristics or conditions.
  • Patients who are part of a vulnerable population may not be eligible. Vulnerable populations include groups that might need special protection or care.
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Investigated drugs

Levosimendan is a medication used in this trial to help improve heart function. It works by increasing the strength of the heart's contractions and improving blood flow. The trial aims to see if Levosimendan can help patients who are being weaned off a machine that supports heart and lung function, known as venoarterial extracorporeal membrane oxygenation (ECMO). The goal is to make it easier for the heart to pump blood on its own after the support from the machine is reduced or stopped.

What is already known about the treatment

Levosimendan – Levosimendan is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating cardiogenic shock, particularly in patients being weaned from venoarterial extracorporeal membrane oxygenation (ECMO). It is a calcium sensitizer and potassium channel opener, which helps improve heart muscle contraction and enhances cardiac output without significantly increasing oxygen demand. This medication is classified as an inotropic agent and is being evaluated for its potential to improve cardiac function and facilitate the weaning process from ECMO support.

Investigated diseases

Cardiogenic Shock – Cardiogenic shock is a severe condition where the heart suddenly cannot pump enough blood to meet the body's needs. It often occurs after a heart attack when the heart's main pumping chamber is damaged. As the heart struggles to supply blood, organs and tissues may not receive enough oxygen, leading to symptoms like rapid breathing, severe shortness of breath, and confusion. The skin may become cool and clammy, and the pulse may be weak and rapid. This condition requires immediate medical attention to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508024-36-00Estimated enrolment46 patientsSponsorAllgemeines Krankenhaus Der Stadt Wien Universitatskliniken

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