Study on Esmolol Hydrochloride, Dobutamine, and Milrinone for Patients with Cardiogenic Shock on V-A ECMO Support

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What is this study about?

This clinical trial is focused on studying the effects of different treatments for patients experiencing cardiogenic shock, a condition where the heart suddenly can’t pump enough blood to meet the body’s needs. The study involves patients who are supported by a medical device called V-A ECMO (Veno-Arterial Extracorporeal Membrane Oxygenation), which helps the heart and lungs function by circulating blood outside the body. The trial will explore the use of three medications: Dobutamine, Milrinone, and Esmolol Hydrochloride. Dobutamine and Milrinone are commonly used to stimulate the heart, while Esmolol Hydrochloride is used to slow down the heart rate.

The purpose of the study is to compare the effects of continuing heart stimulation with Dobutamine and Milrinone against the effects of slowing the heart rate with Esmolol Hydrochloride. This will help determine which approach is safer and more effective for patients with cardiogenic shock. Participants will be randomly assigned to receive either the heart-stimulating medications or the heart-slowing medication. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects accurately.

The study will monitor changes in heart rate and other heart functions over a period of time. Participants will receive their assigned treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The trial will last for a maximum of 14 days, during which various heart-related measurements will be taken to assess the impact of the treatments. The goal is to find the best strategy to manage heart function in patients with cardiogenic shock who are supported by V-A ECMO.

1 joining the study

Participation begins after meeting specific criteria, including being 18 years or older, having received V-A ECMO support for severe heart failure, and having a heart rate of 80 beats per minute or more.

The study focuses on patients who have been on V-A ECMO support for less than 16 hours and are receiving dobutamine at a rate of 2 mcg/kg/min or more.

2 randomization

Participants are randomly assigned to one of two groups: one group continues with beta receptor stimulation, while the other group receives beta receptor inhibition through intravenous medication.

3 medication administration

The study involves the use of three medications: dobutamine, milrinone, and esmolol hydrochloride, all administered intravenously.

Esmolol is used to inhibit beta receptors, and its dosage is monitored over 48 hours.

4 monitoring and assessment

Heart rate changes are measured 24 hours after randomization. The average heart rate is calculated based on observations over a 5-minute period.

Additional assessments include heart function measurements, such as cardiac output and ejection fraction, at baseline, 24, and 48 hours after randomization.

5 secondary evaluations

Secondary evaluations include monitoring for new heart rhythm issues, measuring blood pressure, and assessing heart muscle oxygen use.

Biomarkers related to heart stress and injury are also measured at baseline and 48 hours after randomization.

6 conclusion of participation

The study aims to conclude by April 15, 2025, with the recruitment phase starting on April 15, 2024.

The primary goal is to evaluate the safety and effectiveness of reducing beta receptor stimulation in patients with cardiogenic shock.

Who Can Join the Study?

Must be 18 years or older.
Must have received V-A ECMO support. This is a type of machine that helps the heart and lungs work when they are not doing well on their own, used for severe problems with blood circulation due to heart failure.
Must be within 16 hours after starting V-A ECMO support.
Must be receiving at least 2 micrograms per kilogram per minute of dobutamine. Dobutamine is a medicine that helps the heart pump better.
Must be receiving norepinephrine infusion at a rate of 0.4 micrograms per kilogram per minute or less. Norepinephrine is a medicine that helps increase blood pressure.
Must have a heart rate of 80 beats per minute or more. The heart rhythm can be normal (sinus rhythm) or irregular (atrial fibrillation or atrial flutter) after starting V-A ECMO.

Who Cannot Join the Study?

Patients experiencing cardiogenic shock cannot participate. Cardiogenic shock is a condition where the heart suddenly can’t pump enough blood to meet the body’s needs.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Epuulnf Uvpyfxdijvow Mewblqc Coijrek Rgqfqitbi (vdrvoaa Mor	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	15.04.2024

Trial locations

Investigated drugs:

Beta Blocker (BB)
This medication is used to reduce the stimulation of beta receptors in the body. In this trial, it is administered intravenously to inhibit the activity of these receptors. The goal is to see if this approach is safe and feasible, and to observe its effects on heart rate compared to the usual care, which involves continuing beta receptor stimulation.

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 a significant drop in blood pressure and reduced blood flow to vital organs. As the heart struggles to function, symptoms such as rapid breathing, severe shortness of breath, and confusion may develop. The skin may become cool and clammy due to poor circulation. Without adequate blood flow, organs can begin to fail, worsening the condition. The progression of cardiogenic shock requires immediate medical attention to prevent further complications.

Trial ID:

2024-511805-42-00

Protocol code:

EUCT 2024-511805-42

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Esmolol Hydrochloride, Dobutamine, and Milrinone for Patients with Cardiogenic Shock on V-A ECMO Support

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?