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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier De Tourcoing Tourcoing France
Centre Hospitalier Universitaire De Nimes Nimes France
Hospital Edouard Herriot Lyon France
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Grenoble France
Centre Hospitalier De Valenciennes Valenciennes France
Centre Hospitalier De Maubeuge Maubeuge France
Chorale Du Centre Hospitalier De Lens Lens France
Centre Hospitalier Public Du Cotentin Cherbourg-En-Cotentin France
Centre Hospitalier D Avignon Avignon France
Groupe Hospitalier du Havre – Hôpital Jacques Monod Montivilliers France
Centre Hospitalier De Roubaix Roubaix France
Centre Hospitalier Universitaire d’Orléans Orléans France
Hopital Ambroise Pare Boulogne-Billancourt France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Intercommunal Compiegne Noyon Compiegne France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier De Boulogne Sur Mer Boulogne sur Mer France
Centre Hospitalier Simone Veil De Beauvais Beauvais France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier de Dieppe Dieppe France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
16.06.2021

Trial locations

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.

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 ID:
2024-518251-31-00
Protocol code:
PI2020_843_0057
Trial Phase:
Therapeutic confirmatory (Phase III)

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