NORADRENALINE TARTRATE for Cardiogenic shock

Inclusion criteria

• {"criterion_text":"- 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;\n- Age over 18 years;\n- Enrollment within 3 hours of the acute event;\n- Written informed consent;\n- SOFA score < 2"}

Exclusion criteria

• {"criterion_text":"- Current pregnancy (possibly confirmed by serum B-Hcg dosage);\n- Presence of at least moderate aortic and/or mitral valve disease;\n- Septic or hypovolemic shock;\n- Mechanical complications of acute myocardial infarction (free wall rupture, ventricular septal defect, papillary rupture.\n- Arrhythmic storm, persistent or chronic tachycardic atrial fibrillation.\n- Infusion of inotropes/vasoconstrictors already in progress at the time of randomization.\n- Hypersensitivity to the active substance or any of the excipients\n- Patients with inotrope-dependent chronic heart failure\n- 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\n- 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.\n- Noradrenaline should not be administered concomitantly with:\n- Anesthetics such as cyclopropane and halothane: may increase cardiac excitability which may cause ventricular tachycardia or fibrillation;\n- 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;\n- MAO antidepressants and other MAO inhibitors: may increase the hypertensive effect by reducing sympathomimetic metabolism.\n- 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.\n- Dihydroergotamine: an extreme increase in blood pressure may occur;\n- 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;\n- COMT inhibitors (entacapone): may increase tachycardia, hypertension and arrhythmia;\n- Guanethidine: may cause an increase in blood pressure and risk of arrhythmias.\n- Noradrenaline should not be administered intravenously together with:\n- 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;\n- Cefamandole, cefoxitin, moxalactam, nitrofurantoin, secobarbital, phenobarbital, thiopental;\n- Dobutamine should be administered with caution at the same time as: halothane and cyclopropane as ventricular arrhythmia has been reported\n- Dobutamine is inactivated by alkaline solutions; therefore it should not be mixed with 5% sodium bicarbonate or other alkaline solutions"}

Primary endpoints

• {"endpoint_text":"- Change in blood lactate concentration measured as the difference between the maximum value at baseline: 0-1 hours after randomization and 72 hours after randomization, in the two treatment arms.\n- In case of death: change in blood lactate concentration measured as the difference between the maximum value at baseline: 0-1h after randomization and the last available lactate value from randomization, in the two treatment arms.","definition_or_measurement_approach":"Change in blood lactate concentration measured as the difference between the maximum value at baseline (0-1 hours after randomization) and 72 hours after randomization. In case of death, change measured between baseline maximum (0-1h) and the last available lactate value from randomization."}

Secondary endpoints

• {"endpoint_text":"- death or need for ECMO/LVAD at 72 hours\n- death or need for ECMO/LVAD at discharge\n- change in SOFA score between baseline (0-1 hour from randomization) and 72 hours from randomization and between baseline (0-1 hour from randomization) and 7 days from randomization\n- lactate AUC (0-72 hours)\n- need for additional extra-trial inotrope at 72 hours","definition_or_measurement_approach":"Secondary endpoints include incidence of death or need for ECMO/LVAD at specified timepoints (72 hours and at discharge); change in SOFA score from baseline to 72 hours and to 7 days; lactate area under the curve over 0-72 hours; and requirement for additional extra-trial inotrope at 72 hours."}

Italy

Earliest CTIS Part Ii Submission Date

23-12-2024

Latest Decision Or Authorization Date

11-08-2025

Processing Time Days

231

Number Of Sites

1

Number Of Participants

46

Primary sponsor

Full Name

Azienda Unita' Sanitaria Locale Toscana Sud Est

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy