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

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What is this study about?

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.

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 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 randomization

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

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Regional Et Universitaire De Brest Brest France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Bethune Beuvry Beuvry France
Centre Hospitalier De Haguenau Haguenau France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Centre Hospitalier De Cannes Simone Veil Cannes France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
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Cjwild Hyrmhirbkym Eo Utfmzocsbcnmv Dq Lldsaxt Limoges 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 recruiting
20.09.2020

Trial locations

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.

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 ID:
2024-517839-50-00
Protocol code:
87RI18_0012
NCT ID:
NCT04166331
Trial Phase:
Human Pharmacology (Phase I) – Other

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