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Study on Landiolol Hydrochloride and Sodium Chloride for Reducing Mortality in Patients with Septic Shock and High Heart Rate

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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 a condition known as septic shock, which is a severe infection that causes dangerously low blood pressure and can lead to organ failure. The study is investigating the use of a medication called landiolol hydrochloride, which is administered as a solution through an intravenous infusion. The purpose of the study is to see if reducing the heart rate with landiolol can improve survival rates in patients experiencing septic shock with a fast heart rate and strong heart contractions.

Participants in the study will receive either the landiolol treatment or the standard care, which may include a placebo. The study will monitor patients over a period of 28 days to assess the impact of the treatment on their survival. During this time, researchers will also observe other factors such as the number of days patients need medications to support their heart, the length of time they require mechanical breathing support, and their overall stay in the hospital.

The study aims to provide valuable insights into whether landiolol can be an effective treatment option for patients with septic shock. By comparing the outcomes of those receiving landiolol with those receiving standard care, the study hopes to determine if this medication can help reduce the risk of death in these critically ill patients.

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 study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the medication landiolol hydrochloride, and the other group will receive the standard treatment for your condition.

  2. Step 2

    Medication administration

    If you are in the group receiving landiolol hydrochloride, the medication will be given to you through an intravenous infusion. This means it will be administered directly into your vein using a needle.

    The dosage and frequency of the medication will be determined by the medical team based on your specific needs and condition.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your heart rate and other vital signs will be closely monitored. This is to ensure your safety and to assess the effectiveness of the treatment.

    You will undergo regular assessments, including measurements of your heart function and overall health status.

  4. Step 4

    Follow-up visits

    You will have scheduled follow-up visits with the medical team. These visits are important to track your progress and to make any necessary adjustments to your treatment plan.

    During these visits, you may be asked about any side effects or changes in your condition.

  5. Step 5

    End of study

    The study will conclude 28 days after your initial inclusion. At this point, a final assessment will be conducted to evaluate the outcomes of the treatment.

    The results will help determine the effectiveness of landiolol hydrochloride in comparison to the standard treatment for patients with septic shock and hypercontractility.

Who can join the trial?

6 criteria

  • Age must be 18 years or older.
  • Must be a patient with septic shock. This means having a severe infection causing dangerously low blood pressure that needs medication to keep it up, along with a high level of lactate in the blood.
  • Must have received between 10 and 30 milliliters per kilogram of body weight of fluid, and the body does not respond to more fluids.
  • Heart's left side must be pumping well, with a left ventricular ejection fraction greater than 60%. This is a measure of how well the heart is pumping blood.
  • Must have a fast heartbeat, with a rate of more than 95 beats per minute, and blood pressure is stable for more than one hour.
  • Can be either breathing on their own or with the help of a machine (intubated and ventilated).

Who cannot join the trial?

5 criteria

  • Patients who are not currently hospitalized for **septic shock** with **hypercontractility**. Septic shock is a serious condition that happens when an infection leads to dangerously low blood pressure. Hypercontractility means the heart is pumping too strongly.
  • Patients who are not experiencing **tachycardia**. Tachycardia is when the heart beats faster than normal.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not considered part of a vulnerable population.
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Investigated drugs

Landiolol is a medication used in this clinical trial to help manage heart rate in patients who are experiencing septic shock. Septic shock is a serious condition that occurs when an infection leads to dangerously low blood pressure and organ failure. In this study, landiolol is being tested to see if it can reduce the heart rate in patients with septic shock who also have a fast heartbeat and strong heart contractions. The goal is to see if slowing down the heart rate with landiolol can improve the chances of survival for these patients over a period of 28 days.

What is already known about the treatment

Landiolol – Landiolol is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently being studied in clinical trials for its potential benefits in treating patients who are hospitalized with septic shock and have an overactive heart condition known as hypercontractility. The main therapeutic use being investigated is its ability to reduce heart rate, which may help improve survival rates in these patients. At the molecular level, landiolol works by blocking specific receptors in the heart, which helps to slow down the heart rate and reduce the force of heart contractions. It is classified as a beta-blocker, a type of medication commonly used to manage heart conditions.

Investigated diseases

Septic Shock – Septic shock is a severe and widespread infection that leads to dangerously low blood pressure and abnormalities in cellular metabolism. It begins with an infection that triggers a systemic inflammatory response, causing blood vessels to dilate and leak, leading to a drop in blood pressure. As the condition progresses, organs may receive insufficient blood flow, resulting in organ dysfunction. The heart may initially respond with increased contractility to maintain blood pressure, but this can lead to further complications. Over time, the body's compensatory mechanisms may fail, exacerbating the condition. If not managed, septic shock can lead to multiple organ failure.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518251-31-00Protocol codePI2020_843_0057Estimated enrolment360 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie

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