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Study on Faster Weaning from Ventilators in Critically Ill Patients Using Levosimendan and a Drug Combination

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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 helping patients who have difficulty stopping the use of a breathing machine, known as invasive ventilation. The study will test a treatment using a medication called Levosimendan, which is given through an intravenous infusion, meaning it is delivered directly into the bloodstream. The goal of the study is to see if this medication can help patients spend more days without needing the ventilator within a 28-day period.

Participants in the study will receive either Levosimendan or a placebo, and neither the patients nor the doctors will know which one is being given. This is called a double-blind study. The treatment will last for up to four days, and the patients will be monitored for their ability to breathe on their own, as well as for any side effects like low blood pressure or irregular heartbeats. The study will also look at how long patients stay in the intensive care unit (ICU) and the hospital, and how they feel about their breathing during the study.

The study will also collect information on the safety of Levosimendan and how it is processed in the body. Researchers will track the number of days patients can breathe without support, any need to return to the ventilator, and overall survival rates at 28 and 90 days. The study aims to provide valuable insights into whether Levosimendan can help patients recover more quickly from the need for mechanical breathing support.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either the study medication or a placebo. This process is called randomization and ensures that the study results are unbiased.

  2. Step 2

    Medication administration

    You will receive the study medication, levosimendan, through an intravenous infusion. This means the medication will be given directly into your vein. The concentration of the medication is 2.5 mg/ml.

    The infusion will be administered as part of your treatment while you are in the intensive care unit (ICU).

  3. Step 3

    Monitoring and assessments

    Throughout the study, your health will be closely monitored. This includes checking for any side effects and assessing your progress in weaning from the ventilator.

    Daily assessments will be conducted to evaluate your breathing ability using a tool called the Visual Analogue Scale (VAS).

  4. Step 4

    End of study participation

    Your participation in the study will continue until you have been successfully weaned from the ventilator or until the study period ends, which is up to 28 days from when you started the study.

    After the study period, follow-up assessments may be conducted to evaluate your recovery and overall health status.

Who can join the trial?

5 criteria

  • Must have been on a breathing machine (invasive ventilation) for more than 48 hours.
  • Must have tried and not succeeded in at least one attempt to breathe on their own, known as a spontaneous breathing trial (SBT).
  • Must be older than 18 years.
  • Women who can have children must have a negative pregnancy test (either from blood or urine) before joining the study.
  • Women who are post-menopausal, meaning they are over 60 years old or have not had a menstrual period for 12 months in a row without another medical reason, and have a specific hormone level (follicle-stimulating hormone or FSH) of 40 or more, do not need to use birth control during the study.

Who cannot join the trial?

1 criterion

  • Patients who cannot stop using a machine that helps them breathe, known as invasive ventilation, cannot participate.
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Investigated drugs

Levosimendan is a medication used in this clinical trial. It is designed to help the heart pump more effectively. This medication works by making the heart muscle stronger, which can be particularly helpful for patients who are critically ill and need assistance with breathing. In this study, the goal is to see if using levosimendan can help patients come off a ventilator more quickly, allowing them to breathe on their own sooner.

What is already known about the treatment

Levosimendan – Levosimendan is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its potential to help patients who have difficulty being weaned off invasive ventilation, which is a machine that helps them breathe. The main therapeutic use being explored is to increase the number of days patients can breathe without the help of a ventilator. At the molecular level, levosimendan works by making the heart muscle more sensitive to calcium, which helps the heart pump more effectively without using more energy. It is classified as a calcium sensitizer and inotropic agent, which means it helps improve heart function.

Investigated diseases

Failure to wean from invasive ventilation – This condition occurs when a patient is unable to transition from mechanical ventilation to independent breathing. It often arises in individuals who have been on ventilators for extended periods due to severe respiratory or systemic illnesses. The inability to wean can be due to factors such as weakened respiratory muscles, lung disease, or other underlying health issues. Patients may experience difficulty breathing, fatigue, and reliance on the ventilator for oxygen support. Over time, this condition can lead to complications such as muscle atrophy and increased risk of infections. The progression of this condition requires careful monitoring and management to support the patient's respiratory function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518810-23-00Protocol codePaNaMa ID: 116348Estimated enrolment250 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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