Authorised Therapeutic use (Phase IV) Cardiogenic shock

"Comparison between norepinephrine and dobutamine in patients with cardiogenic shock"

EU CTIS ID: 2024-520399-84-00

What this study is testing

Evaluate the difference in lactate variation associated with one of the two therapeutic schemes, norepinephrine versus dobutamine plus norepinephrine.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • - Cardiogenic shock with: systolic systemic arterial pressure (SBP) < 90 mmHg or mean arterial pressure (MAP) < 60 mmHg for at least 30 consecutive minutes and need for pharmacological support (inotropes and/or vasopressors) to maintain an SBP > 90 mmHg or MAP > 60 mmHg; - Age over 18 years; - Enrollment within 3 hours of the acute event; - Written informed consent; - SOFA score < 2

You likely can't join if

  • - Current pregnancy (possibly confirmed by serum B-Hcg dosage); - Presence of at least moderate aortic and/or mitral valve disease; - Septic or hypovolemic shock; - Mechanical complications of acute myocardial infarction (free wall rupture, ventricular septal defect, papillary rupture. - Arrhythmic storm, persistent or chronic tachycardic atrial fibrillation. - Infusion of inotropes/vasoconstrictors already in progress at the time of randomization. - Hypersensitivity to the active substance or any of the excipients - Patients with inotrope-dependent chronic heart failure - Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or 5 half-lives of the study drug, whichever is longer - Any previous or ongoing medical condition or clinically significant laboratory value at screening that, in the opinion of the investigator, may pose a risk to patient safety, interfere with study compliance and follow-up, or confound the interpretation of the data throughout the study period. - Noradrenaline should not be administered concomitantly with: - Anesthetics such as cyclopropane and halothane: may increase cardiac excitability which may cause ventricular tachycardia or fibrillation; - tricyclic antidepressants: may enhance the effects of noradrenaline causing hypertension, cardiac arrhythmias and tachycardia. If it is necessary to administer these drugs together, careful monitoring must be performed and the dose of noradrenaline must be reduced; - MAO antidepressants and other MAO inhibitors: may increase the hypertensive effect by reducing sympathomimetic metabolism. - Neuroleptics: may decrease the effectiveness of noradrenaline. If it is necessary to administer these drugs together, an adjustment of the dose of noradrenaline is necessary to maintain or achieve the expected therapeutic effect. It is recommended to monitor blood pressure. - Dihydroergotamine: an extreme increase in blood pressure may occur; - Antibiotics (linezolid): a hypertensive crisis may be triggered or worsened. Therefore, it is necessary to reduce the dose of noradrenaline and adjust it to achieve the desired effect; - COMT inhibitors (entacapone): may increase tachycardia, hypertension and arrhythmia; - Guanethidine: may cause an increase in blood pressure and risk of arrhythmias. - Noradrenaline should not be administered intravenously together with: - Basic buffered antibiotics. Noradrenaline is labile in an alkaline environment and caution should be exercised in preparations when a final pH greater than 6 is reached; - Cefamandole, cefoxitin, moxalactam, nitrofurantoin, secobarbital, phenobarbital, thiopental; - Dobutamine should be administered with caution at the same time as: halothane and cyclopropane as ventricular arrhythmia has been reported - Dobutamine is inactivated by alkaline solutions; therefore it should not be mixed with 5% sodium bicarbonate or other alkaline solutions

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.