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Study on the Effects of Landiolol Hydrochloride for Patients with Microcirculatory Issues During Septic 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 a medication called landiolol hydrochloride on patients experiencing septic shock. Septic shock is a serious condition that occurs when an infection leads to dangerously low blood pressure and abnormalities in blood flow. The medication being tested, known by its brand name RAPIBLOC, is administered as a solution through an infusion. The purpose of the study is to evaluate how effective landiolol hydrochloride is in improving blood flow in small blood vessels compared to the usual treatment for rapid heart rate, which is common in septic shock.

During the study, participants will receive a continuous infusion of landiolol hydrochloride for a period of 12 hours. The goal is to reduce the heart rate by up to 15% and observe the effects on the small blood vessels' ability to react and function properly. The study will also monitor changes in heart function, skin color, urine output, and levels of certain substances in the blood that indicate inflammation and blood flow. These observations will help determine if the medication can improve the condition of patients with septic shock.

The trial aims to provide valuable insights into whether landiolol hydrochloride can be a beneficial treatment option for managing septic shock, particularly in improving the function of small blood vessels. The study is expected to continue until August 2025, with the recruitment of participants having started in July 2022. The findings from this research could potentially lead to better treatment strategies for patients suffering from this critical condition.

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

    Participation begins after meeting specific criteria, including having a heart rate over 100 beats per minute due to septic shock, being at least 18 years old, and having social security affiliation.

    Consent must be provided by the patient or a family member.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the patient's condition and eligibility for the study.

    This includes ensuring the patient has been managed for at least 6 hours but less than 24 hours to avoid complications from prolonged treatment.

  3. Step 3

    Medication administration

    The patient receives a continuous intravenous infusion of landiolol hydrochloride.

    The dosage ranges from 0.5 to 10 micrograms per kilogram per minute, administered for 12 hours.

    The goal is to reduce the heart rate by up to 15%.

  4. Step 4

    Monitoring and evaluation

    Throughout the infusion, the patient's microcirculatory vascular reactivity is monitored.

    Additional parameters such as cardiac output, clinical perfusion, and inflammation markers are evaluated at specific time points.

  5. Step 5

    Completion of treatment

    After the 12-hour infusion period, the treatment phase concludes.

    Final assessments are conducted to measure changes in the monitored parameters.

Who can join the trial?

10 criteria

  • The patient must have **microcirculatory abnormalities** during **septic shock**. This means there are issues with the small blood vessels during a severe infection that affects the whole body.
  • The patient must have **non-compensatory sinus tachycardia**. This is a condition where the heart beats faster than normal, and the doctor believes it needs treatment.
  • The patient must be in a state of **resuscitated and stabilized septic shock**. This means they have been treated for septic shock and their condition is stable.
  • The patient must have a **heart rate (HR) greater than 100 beats per minute** due to sepsis, which is a serious infection.
  • The patient must need **norepinephrine** to keep their blood pressure above a certain level. Norepinephrine is a medication that helps maintain blood pressure.
  • The patient must have been managed for at least 6 hours but less than 24 hours. This is to ensure proper diagnosis and treatment without complications from prolonged treatment.
  • The patient must not have had an increase in norepinephrine dosage in the last two hours. This ensures that their blood pressure is stable.
  • The patient or a family member must sign an **informed consent** form, which is a document that explains the study and confirms their agreement to participate.
  • The patient must be **18 years or older**.
  • The patient must have **Social Security affiliation**, meaning they are registered with the social security system.

Who cannot join the trial?

5 criteria

  • Patients who do not have microcirculatory abnormalities during septic shock. This means that if your small blood vessels are not functioning abnormally during a severe infection that affects the whole body, you cannot participate.
  • Patients who are not within the specified age range. The study is open to certain age groups, so if you are outside these age ranges, you cannot participate.
  • Patients who are not part of the specified clinical trial groups. The study is designed for specific groups of people, so if you do not belong to these groups, you cannot participate.
  • Patients who are not male or female. The study includes both men and women, so if you do not identify as either, you cannot participate.
  • Patients who are not considered part of a vulnerable population. This means that if you are not in a group that might need special protection or care, you cannot participate.
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Investigated drugs

Landiolol is a medication used in this clinical trial to study its effects on the microcirculation during septic shock. It is administered through a continuous intravenous infusion. The main goal is to see how well it can lower heart rate and improve blood flow in small blood vessels compared to standard treatments for managing fast heart rates.

What is already known about the treatment

Landiolol – Landiolol is administered as a continuous intravenous infusion, typically at a dosage of 0.5 to 10 micrograms per kilogram per minute over a 12-hour period. It is currently being studied in clinical trials for its effects on microcirculatory abnormalities in patients experiencing septic shock. The main therapeutic indication for Landiolol is to manage heart rate and improve microcirculatory vascular reactivity in these patients. At the molecular level, Landiolol works by selectively blocking beta-1 adrenergic receptors, which helps to reduce heart rate and improve blood flow. It is classified pharmacologically as a beta-blocker.

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 occurs when an infection in the body triggers an extreme immune response, causing inflammation and blood clotting throughout the body. This can result in reduced blood flow to vital organs, leading to organ dysfunction. The condition progresses rapidly and can cause symptoms such as confusion, difficulty breathing, and a rapid heart rate. Microcirculatory abnormalities, where small blood vessels fail to deliver adequate blood flow, are common during septic shock. These abnormalities can further impair organ function and complicate the body's ability to recover from the infection.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512757-24-00Protocol codeAPHP191047Estimated enrolment44 patientsSponsorAssistance Publique Hopitaux De Paris

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