Comparison of Landiolol versus standard of care for prevention of mortality in patients hospitalized for a septic shock with hypercontractlity: an open label prospective randomized study
This research is looking into a new treatment called Landiolol for adults who are very unwell in hospital with a severe type of infection called septic shock. These patients also have a heart that is beating too fast and working too hard (hypercontractility). The study wants to find out if Landiolol is better than the standard care we currently give to prevent deaths during the first 28 days. Researchers will compare how patients recover, their heart rate, how long they need other medicines or breathing support, and their time in hospital. This is a Phase 3 study, meaning it's one of the final stages before a new treatment might become widely available.
At a glance
What is this study about?
This study is for adults who are seriously ill in intensive care because of a severe infection that has led to what doctors call septic shock. In septic shock, your body reacts very strongly to an infection, affecting many organs and sometimes making your blood pressure dangerously low. Some patients with septic shock also have a heart that is beating too fast and working too hard – this is called hypercontractility. Doctors believe that calming the heart a bit might help these very sick patients.
The main goal of this research is to compare a new medicine called Landiolol with the standard care that patients usually receive. Landiolol is a type of medicine that can help slow down and relax an overworking heart. The study wants to know if patients who receive Landiolol are more likely to survive after 28 days compared to those receiving standard care. This is a 'randomized' study, which means patients will be put into groups by chance, like flipping a coin, to make sure the comparison is fair.
Researchers will also be looking at many other things to see how Landiolol might help. This includes how quickly a patient's heart rate reduces, how long they need other strong medicines to support their blood pressure (called catecholamines), how long they need a breathing machine (mechanical ventilation), and how long they stay in intensive care and hospital. They'll also monitor how the patients' overall health changes over time and if there are any sudden heart problems.
Key takeaways
- This study compares Landiolol with standard care for severe infection (septic shock).
- It's for patients whose heart is beating too fast and hard.
- The main goal is to see if Landiolol improves survival at 28 days.
- Patients are randomly assigned to receive either the new medicine or usual treatment.
- Close monitoring will happen for up to 28 days.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or older. The study is open to both men and women.
The most important criteria are that you must be in hospital due to a very severe infection causing septic shock, and your heart must be beating too fast and working too hard, a condition doctors call hypercontractility.
Beyond these main points, the medical team will check other specific health details to make sure the study is right for you and safe. They will discuss all the requirements with you or your family if you're unable to speak for yourself.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an adult (18 years or older)?
- Are you currently in hospital with a very severe infection (septic shock)?
- Have doctors identified that your heart is beating too fast and working too hard?
- Are you able to or is your legal representative able to give consent?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to either receive the study medicine (Landiolol) or the standard treatment. The Landiolol would be given through a drip (infusion) into your vein. You would continue to receive the standard medical care appropriate for septic shock.
The research team would closely monitor your health throughout your hospital stay. This includes regular checks of your heart rate, blood pressure, and other vital signs. They would also take blood samples and perform examinations to track your progress and see how your body is responding to treatment. They will look at how long you need certain medications or breathing support, and how long you stay in the intensive care unit and the main hospital ward. Follow-up observations would continue up to 28 days after you join the study, even if you are discharged sooner.
Potential risks and benefits
Locations (1)
- —UnverifiedFrance
Common questions
What is septic shock?
Septic shock is a life-threatening condition caused by your body's overwhelming response to an infection. It can lead to dangerously low blood pressure and organ damage.
What is 'hypercontractility'?
Hypercontractility means your heart is beating too fast and forcefully, working harder than it should for your body's condition.
What is Landiolol?
Landiolol is a medicine that helps to slow down and relax your heart. It's given through a drip into your vein.
Will I definitely get the new medicine?
No, because this is a randomized study, you will be put into a group by chance. You might receive Landiolol or the usual standard care.
How long does the study last for each person?
Researchers will closely monitor your health for up to 28 days after you join the study, even if you are discharged from hospital before then.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.