Not yet recruitingNAINTERVENTIONAL

Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients

This research is about finding the best way to use common antibiotics, called beta-lactams, in very sick patients. These patients might be in intensive care because of conditions like heart problems or after heart surgery, and they are also on a special life support machine called VA-ECMO. When someone is very ill or on VA-ECMO, their body handles medicines differently, which makes it harder to know the right dose of antibiotics. This study aims to understand why some patients don't get enough of the antibiotic in their blood and to find ways to make sure the treatment works well to fight serious infections. The goal is to improve how these life-saving antibiotics are given to help patients recover.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

225

Start

01 Sep 2024

Estimated completion

01 Sep 2028

Cardiogenic Shock Post-cardiac Surgery Cardiac Arrest Extracorporeal Membrane Oxygenation Complication Infections

What is this study about?

This study is investigating something called 'beta-lactam antibiotics.' These are common and powerful medicines used to treat serious infections, especially in intensive care units. When people are critically ill, their bodies can react very differently to medicines. Things like how much fluid they're given, other medications they're on, or how well their organs are working can change how quickly their body uses up or gets rid of antibiotics. This makes it tricky for doctors to know the exact right dose to give a patient to fight their infection effectively.

The challenge becomes even bigger for patients who are on a special life support machine called VA-ECMO (Veno-Arterial Extracorporeal Membrane Oxygenation). This machine helps keep blood pumping and oxygen flowing when the heart and lungs are struggling. While VA-ECMO is life-saving, it can also significantly change how antibiotics move through the body. For example, the machine itself might absorb some of the medicine, or the extra fluid needed for the machine can dilute the antibiotic in the bloodstream. Because of these changes, the usual antibiotic doses might not work as intended for patients on VA-ECMO.

Currently, there aren't clear guidelines for how to give these specific antibiotics to patients on VA-ECMO. This study aims to fill that gap. By looking at how these antibiotics behave in patients on VA-ECMO, researchers hope to identify factors that prevent the antibiotics from reaching effective levels in the blood. Ultimately, the goal is to develop better ways to dose these critical medicines, ensuring that patients receive the most effective treatment to fight their infections and improve their chances of recovery.

Key takeaways

This study focuses on improving antibiotic use in critically ill patients.
It specifically looks at how antibiotics called beta-lactams work in patients on VA-ECMO life support.
The goal is to find the best way to dose these antibiotics to fight serious infections effectively.
Participation involves extra blood tests to monitor antibiotic levels.
The findings could help doctors improve treatment for future patients.

Who may be eligible?

You might be able to take part in this study if you are a patient receiving a special type of life support called VA-ECMO. You would also need to be starting a new course of certain types of antibiotics (specifically Piperacillin-Tazobactam, Cefepime, or Meropenem) while you are on the VA-ECMO machine, and doctors expect you to live for at least another 24 hours.

Before you can join, you or a trusted family member would need to give your permission for you to take part. This ensures you understand what the study involves and agree to participate.

However, some situations would mean you cannot join the study. For example, if you are pregnant or breastfeeding, if you are already taking the antibiotics they are studying before starting VA-ECMO, or if you can't take beta-lactam antibiotics for any medical reason. Also, if you are involved in certain legal situations or are already part of another study at the same time, you wouldn't be able to participate.

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 currently on a VA-ECMO machine?
Are you about to start a new course of specific antibiotics (Piperacillin-Tazobactam, Cefepime, or Meropenem)?
Do doctors expect you to live for at least 24 hours?
Are you able to provide consent (or can a trusted family member provide it for you)?
Are you NOT pregnant or breastfeeding?
Are you NOT already taking these specific antibiotics before starting VA-ECMO?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the main thing that will happen is that your doctors will closely monitor the levels of your antibiotics. This is done by taking extra blood samples at specific times after you receive your antibiotic dose. These blood tests will help researchers understand how your body handles the medication while you are on VA-ECMO. You will be receiving your antibiotics as you normally would for your treatment; the study won't change your prescribed medication or how it's given. The total duration of your participation in the study would depend on how long you are receiving the specific antibiotics they are monitoring.

Potential risks and benefits

Taking part in this study could potentially help improve antibiotic treatment for future patients on VA-ECMO, as the insights gained might lead to more effective dosing strategies. For you, the main 'benefit' is that your antibiotic levels will be closely monitored, which might help your doctors adjust your treatment to ensure the medicine is working as best as possible. The primary 'risk' is the need for extra blood samples, which may cause minor discomfort or bruising. There is also a very small risk of infection from blood draws, though this is rare with standard hospital procedures. You are always free to withdraw from the study at any time without explaining why, and this will not affect the care you receive.

Locations (5)

CHU de Clermont Ferrand - Hôpital Gabriel Montpied
Verified postcode
Clermont-Ferrand, France
CHU Dijon-Bourgogne
Verified postcode
Dijon, France
Aphp Pitie Salpetriere
Verified postcode
Paris, France
CHU ROUEN - Hôpital Charles-Nicolle
Verified postcode
Rouen, France
Hôpital Rangueil - CHU Toulouse
Verified postcode
Toulouse, France

Common questions

What is VA-ECMO?

VA-ECMO is a special machine that helps your heart and lungs work when they are very sick, by pumping and oxygenating your blood outside your body.

What are beta-lactam antibiotics?

These are a common type of strong medicine used to treat serious bacterial infections, like penicillin-based drugs.

Why is this study important for patients on VA-ECMO?

Because VA-ECMO changes how your body handles medicines, this study wants to find the best way to give antibiotics so they work effectively to fight infections.

Will I get extra medicine for this study?

No, you will receive the same antibiotics your doctor prescribes. The study focuses on monitoring how that medicine works in your body.

Will taking part in this study affect my normal medical care?

No, your regular medical care and treatment will continue as usual. This study involves extra monitoring to help gather information.

How to find out more

ALEXANDRE BEHOUCHE, MD

abehouche@chu-grenoble.fr 04 76 76 68 79 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.