Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Adjunctive DobutAmine in sePtic cardiomyopathy with Tissue hypoperfusion: a randomized controlled multi-center trial

This study is investigating a treatment for a serious condition called septic cardiomyopathy, which is a complication of severe blood poisoning (sepsis). In septic cardiomyopathy, the heart doesn't pump blood effectively, leading to tissues not getting enough oxygen. The research is testing a drug called Dobutamine to see if it can help improve how well organs are working. Doctors will compare participants receiving Dobutamine with those receiving a placebo (a dummy treatment). They will measure changes in organ function, monitor heart health, and check for any side effects to understand if Dobutamine can safely and effectively help people recover from this severe illness. The study aims to find better ways to treat this life-threatening condition.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Centre Hospitalier Et Universitaire De Limoges

Enrolment target

136

Start

10 Oct 2024

sepsis

What is this study about?

When someone has severe blood poisoning, known as sepsis, it can sometimes affect their heart. This complication is called septic cardiomyopathy. It means the heart struggles to pump enough blood around the body, which can lead to vital organs not getting enough oxygen. This study is looking into whether a medicine called Dobutamine can help people with this condition.

Dobutamine is a drug that can help the heart pump blood more effectively. Researchers want to see if giving Dobutamine to patients with septic cardiomyopathy can improve how well their organs are working. They will carefully monitor participants to see if there are improvements in their overall health and organ function. This includes checking things like blood tests and how the heart is beating.

This is a Phase III and IV study, which means the drug has already been tested to some extent, and now researchers are looking at its effectiveness and safety in a larger group of people. The goal is to find better and safer ways to treat people who are very unwell with sepsis and heart problems, potentially improving their recovery and reducing serious complications.

Key takeaways

This study is for adults with severe blood poisoning (sepsis) affecting their heart.
It tests a drug called Dobutamine to improve heart and organ function.
Participants will receive either Dobutamine or a placebo, given by IV drip.
Careful monitoring of heart function and organ health will occur throughout.
The study aims to find better treatments for this serious condition.
Regular follow-up checks are part of the study for several months.

Who may be eligible?

This study is looking for adults who are at least 18 years old. People of any age above 18, and of any gender, can potentially take part.

To be included, you would need to have severe blood poisoning (sepsis) that has affected your heart's ability to pump blood effectively, leading to your body's tissues not getting enough oxygen. This is a very serious condition, and potential participants would already be in intensive care.

There will be other medical checks to make sure the study is right and safe for you. These checks are important to ensure that the study results are clear and that all participants are treated with the utmost care.

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 18 years old or older?
Do you have severe blood poisoning (sepsis)?
Has your heart's ability to pump blood been affected by sepsis?
Are you currently receiving care in an intensive care unit (ICU)?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you would receive either the study drug, Dobutamine, or a placebo (a dummy treatment). This would be given through a drip (infusion) into your vein. Doctors would carefully watch your progress, including blood tests to check how your organs are working and measurements of your heart function, especially over the first three days.

Throughout your stay in the intensive care unit (ICU) and hospital, doctors would continue to monitor important health markers. This includes checking your blood pressure, heart rate, and the need for any other treatments that help support your organs, like breathing machines or kidney dialysis.

There will also be checks at 7 days, 28 days, and 90 days after joining the study to see how you are recovering. The total duration of your participation in terms of follow-up would be a few months, though the most intensive monitoring would be during your hospital stay.

Potential risks and benefits

Participating in this study might offer a potential benefit if Dobutamine helps improve your heart function and overall recovery from severe sepsis. However, there's also a chance you might receive a placebo, meaning you wouldn't get the active study drug. As with any medication, there are potential risks, including side effects like changes in blood pressure, heart rate, or other heart problems. All participants will be closely monitored for any unexpected or serious reactions. You would always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is sepsis?

Sepsis is a life-threatening condition caused by your body's extreme response to an infection. It can cause organ systems to malfunction.

What is Dobutamine?

Dobutamine is a medicine given into a vein that helps your heart pump blood more effectively.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the study drug but doesn't contain any active medicine. It helps researchers compare the real drug's effects.

Will I know if I'm getting Dobutamine or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you're receiving Dobutamine or the placebo until after the study is complete, for the most accurate results.

How long will the study last for me?

The main part of the study involves monitoring during your hospital stay, with follow-up health checks at 7 days, 28 days, and 90 days after you join.