Study on Isoflurane, Propofol, and Dobutamine Hydrochloride for Sedation in Adults with Severe Cardiogenic Shock on ECMO

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What is this study about?

This clinical trial is focused on patients experiencing severe cardiogenic shock, a condition where the heart suddenly can’t pump enough blood to meet the body’s needs. These patients are supported by a machine called venoarterial extracorporeal membrane oxygenation (VA-ECMO), which helps circulate blood through the body. The study is investigating the use of a medication called isoflurane, which is inhaled to help sedate patients who are on mechanical ventilation. Sedation is important to keep patients comfortable and stable while they are on life support.

In addition to isoflurane, the study involves other medications like propofol and midazolam, which are commonly used for sedation in intensive care settings. The purpose of the study is to assess how effective inhaled isoflurane is in improving outcomes for these patients, specifically looking at survival rates and the number of days patients can breathe without the help of a ventilator within 28 days of starting ECMO support.

The study will follow patients for up to 28 days, monitoring various outcomes such as survival, the need for heart transplants or additional heart support devices, and the number of days patients are free from ECMO, inotropes (medications that help the heart pump more effectively), and intensive care. It will also track the use of other sedative medications and any side effects that may occur. The trial aims to provide valuable information on the best sedation practices for patients with severe heart conditions requiring advanced life support.

1 joining the trial

Upon joining the trial, you will be assessed to ensure you meet the necessary criteria. This includes having severe cardiogenic shock and being on venoarterial extracorporeal membrane oxygenation (VA-ECMO) support for less than 24 hours.

You must also be on invasive mechanical ventilation and receiving either propofol or midazolam at the time of joining the trial.

2 initial treatment phase

During this phase, you will continue to receive sedation through inhaled isoflurane using a special device designed to conserve the anesthetic.

The goal is to maintain a specific level of sedation, measured by the Richmond agitation scale, within a range of -1 to -4.

3 monitoring and adjustments

Your condition will be closely monitored to assess the effectiveness of the treatment. This includes tracking the number of days you are alive without the need for mechanical ventilation over a 28-day period.

Adjustments to your medication, including daily doses of propofol and midazolam, may be made to ensure the desired level of sedation is achieved.

4 evaluation of outcomes

The primary outcome being evaluated is a combination of survival and the number of days you are free from mechanical ventilation within 28 days of starting ECMO.

Secondary outcomes include overall survival, the number of days free from ECMO, and the number of days free from intensive care unit (ICU) care.

5 completion of trial

The trial will conclude after the 28-day period, and your participation will help assess the effectiveness of inhaled isoflurane for sedation in patients with cardiogenic shock.

Your health and safety will continue to be a priority throughout the trial, with regular assessments to monitor for any side effects or complications.

Who Can Join the Study?

Must be an adult patient.
Must have severe cardiogenic shock and be on venoarterial ECMO support for less than 24 hours. ECMO is a machine that helps with heart and lung function.
Must be on invasive mechanical ventilation for less than 48 hours. This means using a machine to help with breathing.
Must be receiving medications like propofol and/or midazolam at the time of joining the study. These are medicines used to keep you calm or asleep.
Expected to need the breathing machine and sedation for at least 24 hours, with a prescribed Richmond agitation scale target within the range of -1 to -4. This scale measures how awake or calm you are.
Must have social security registration (except AME).
Both male and female patients can participate.

Who Cannot Join the Study?

Patients who have been on venoarterial ECMO support for more than 24 hours. ECMO stands for extracorporeal membrane oxygenation, a machine that helps with heart and lung function.
Patients who are not adults. This means anyone under the age of 18 cannot participate.
Patients who are not experiencing severe cardiogenic shock. This is a condition where the heart suddenly can’t pump enough blood to meet the body’s needs.
Patients who are not able to use the inhaled medication being tested in the study.
Patients who are part of a vulnerable population that requires special protection in clinical trials.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France
Cina Dd Nacil	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	03.03.2025

Trial locations

Investigated drugs:

Isoflurane is a medication used to help patients relax and stay calm while they are on a breathing machine. In this trial, it is given to patients who are experiencing heart problems and are on a special life-support machine called ECMO. The goal is to see if this medication can help improve their chances of survival and reduce the time they need to be on the breathing machine. Isoflurane is inhaled, meaning patients breathe it in, and it works by calming the brain and body, making it easier for patients to rest and recover.

Investigated diseases:

Cardiogenic shock

Cardiogenic Shock – Cardiogenic shock is a condition where the heart suddenly cannot pump enough blood to meet the body’s needs. It often occurs after a severe heart attack, leading to reduced blood flow to vital organs. As the condition progresses, patients may experience rapid breathing, severe shortness of breath, and a weak pulse. The skin may become cool and clammy, and there may be confusion or loss of consciousness. Without adequate blood flow, organs can begin to fail, worsening the patient’s condition. Cardiogenic shock requires immediate medical attention to prevent further complications.

Trial ID:

2023-510261-94-00

Protocol code:

APHP230844

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Isoflurane, Propofol, and Dobutamine Hydrochloride for Sedation in Adults with Severe Cardiogenic Shock on ECMO

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?