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Study on Dobutamine and Glucose for Patients with Septic Cardiomyopathy and Low Blood Flow

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Dobutamine in patients with a condition known as septic cardiomyopathy. Septic cardiomyopathy occurs when the heart's ability to pump blood is weakened due to sepsis, a severe infection that spreads throughout the body. The study aims to understand how Dobutamine, when used alongside standard treatments, affects the functioning of organs in patients experiencing septic shock, a serious complication of sepsis where blood pressure drops to dangerously low levels.

Participants in the study will receive either Dobutamine or a placebo, which is a substance with no active medication. The treatment will be administered through an intravenous infusion, meaning it will be delivered directly into the bloodstream. The study will monitor the participants over a period of several days to observe changes in their health, particularly focusing on how their organs are functioning. This includes looking at heart function, blood pressure, and other vital signs to determine the impact of the treatment.

The goal of the study is to gather information on whether Dobutamine can help improve outcomes for patients with septic cardiomyopathy by supporting their heart and other organs during a critical time. The findings from this research could potentially lead to better treatment strategies for managing septic shock and its effects on the heart. Participants will be closely monitored by medical professionals throughout the study to ensure their safety and well-being.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, informed consent is required. This means understanding the trial's purpose, procedures, and potential risks and benefits before agreeing to participate.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm eligibility. This includes checking for **septic shock** and **septic cardiomyopathy** using specific medical criteria.

    Eligibility criteria include being 18 years or older, having a suspected or confirmed infection causing organ dysfunction, and requiring medication to maintain blood pressure.

  3. Step 3

    Randomization

    Participants are randomly assigned to receive either **dobutamine** or a placebo. This process ensures that the trial results are unbiased.

  4. Step 4

    Treatment administration

    The treatment involves an **intravenous infusion** of either **dobutamine** or a placebo. The infusion is administered continuously over a specified period.

    The dosage and duration of the infusion are determined by the medical team based on individual needs and trial protocols.

  5. Step 5

    Monitoring and assessments

    Regular monitoring is conducted to assess the effects of the treatment. This includes measuring blood pressure, heart rate, and other vital signs.

    Additional assessments may include blood tests to check **lactate levels** and **oxygen saturation** to evaluate tissue oxygenation.

  6. Step 6

    Follow-up assessments

    Follow-up assessments are conducted on Day 1, Day 2, and Day 3 after starting the treatment. These assessments help track changes in organ function and overall health.

    Echocardiography may be performed to evaluate heart function and structure.

  7. Step 7

    End of trial participation

    Participation in the trial concludes after the final assessments. The medical team will provide information on any further steps or follow-up care needed.

Who can join the trial?

6 criteria

  • Must be 18 years or older and currently in the Intensive Care Unit (ICU).
  • Must have septic shock, which means a severe infection causing organ problems and low blood pressure that doesn't improve with fluids.
  • Must need medication called vasopressors (like Norepinephrine) to keep blood pressure stable.
  • Must have a lactate level greater than 2 mmol/L in the 24 hours before joining the study. Lactate is a substance in the blood that can be high when the body is under stress.
  • Must have septic cardiomyopathy, which is a heart problem due to sepsis. This is shown by a heart test (echocardiogram) showing a low heart pumping ability (ejection fraction ≤ 40%) and low blood flow out of the heart.
  • Must give informed consent, meaning you agree to participate after understanding the study details.

Who cannot join the trial?

6 criteria

  • Patients who do not have **septic shock**. Septic shock is a severe infection that affects the whole body and can lead to organ failure.
  • Patients who are not stabilized under **vasopressor support**. Vasopressors are medications that help raise blood pressure in critically ill patients.
  • Patients who do not have **septic cardiomyopathy** as shown by an echocardiogram. Septic cardiomyopathy is a heart condition caused by severe infection, and an echocardiogram is a test that uses sound waves to create pictures of the heart.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the selected clinical trial groups.
  • Patients who are not considered part of the vulnerable population selected for the study.
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Investigated drugs

Dobutamine is a medication used in this clinical trial to help improve heart function in patients who are experiencing septic cardiomyopathy, a condition where the heart is weakened due to severe infection. It works by stimulating the heart to pump more effectively, which can help improve blood flow to vital organs. This medication is given to patients who are already receiving other treatments for septic shock, such as fluids and medications to support blood pressure, to see if it can further help in reducing organ failure.

What is already known about the treatment

Dobutamine – Dobutamine is administered as an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials for its potential benefits in treating septic cardiomyopathy, a condition associated with sepsis where the heart's ability to pump blood is impaired. The main therapeutic indication for dobutamine in this context is to support heart function and improve blood flow in patients experiencing septic shock. At the molecular level, dobutamine works by stimulating beta-1 adrenergic receptors in the heart, which increases heart rate and strength of contraction, thereby enhancing cardiac output. It is classified pharmacologically as a sympathomimetic drug, which means it mimics the effects of the sympathetic nervous system to increase heart activity.

Investigated diseases

Sepsis – Sepsis is a severe medical condition that occurs when the body's response to an infection causes widespread inflammation. This inflammation can lead to blood clots and leaky blood vessels, impairing blood flow and depriving organs of nutrients and oxygen. As the condition progresses, it can cause tissue damage, organ failure, and, if not managed, can worsen over time. The progression of sepsis can be rapid, with symptoms such as fever, increased heart rate, increased breathing rate, and confusion. In severe cases, it can lead to septic shock, characterized by a significant drop in blood pressure. Early recognition and management are crucial to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517839-50-00Protocol code87RI18_0012Estimated enrolment136 patientsSponsorCentre Hospitalier Et Universitaire De Limoges

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