Study on the Effects of Landiolol Hydrochloride for Patients with Microcirculatory Issues During Septic Shock

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	18.07.2022

Trial locations

Investigated drugs:

Landiolol Hydrochloride

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.

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 ID:

2024-512757-24-00

Protocol code:

APHP191047

NCT ID:

NCT04931225

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Landiolol Hydrochloride for Patients with Microcirculatory Issues During Septic Shock

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?