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Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation (REMAP ECMO) - Beta receptor modulation trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511805-42-00
Acronym
EUCT 2024-511805-42
Enrollment
20
Registered
2024-05-10
Start date
2024-05-23
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic shock

Brief summary

Change (delta) in heart rate 24 hours after randomization. The average heart rate will be calculated based on all observations during 5 minutes.

Detailed description

Percentage of patients having received esmolol and the maximum median dosages after 48 hours., Vasopressor score at baseline, 24 and 48 hours after randomization, using the calculation as described in literature, excluding inotropic medication, Occurrence of new onset ventricular and/or atrial arrhythmias during the first 48 hours after randomization, Left ventricular outflow tract velocity time integral (LVOT VTI), ejection fraction (EF), tricuspid annular plane systolic excursion (TAPSE) at baseline, 24 and 48 hours after randomization, Cardiac output, pulmonary capillary wedge pressure, central venous pressure (measured by pulmonary artery catheter), SVO2 at baseline, 24 and 48 hours after randomization, Lactate level at baseline, 24 and 48 hours after randomization, Troponin at 24 and 48 hours after randomization and Area Under the Curve (AUC), Myocardial oxygen consumption estimated by calculating the pressure volume (PV) area on basis of non-invasive PV loop assessments using echocardiography and pulmonary artery catheter measurements at 24 and 48 hours after randomization, Biomarkers on cardiac stretch and cardiac injury at baseline and 48 hours after randomization, FiO2 suppletion and PEEP level at 24 and 48 hours after randomization, Plasma metanephrines and normetanephrine levels at baseline and 24 hours after randomization

Interventions

DRUGEsmolol HCl LYO Orpha 2500 mg poeder voor concentraat voor oplossing voor infusie
DRUGMilrinon Hikma 1 mg/ml oplossing voor injectie
DRUGDobutamine-hameln 5 mg/ml i.v. infusievloeistof

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change (delta) in heart rate 24 hours after randomization. The average heart rate will be calculated based on all observations during 5 minutes.

Secondary

MeasureTime frame
Percentage of patients having received esmolol and the maximum median dosages after 48 hours., Vasopressor score at baseline, 24 and 48 hours after randomization, using the calculation as described in literature, excluding inotropic medication, Occurrence of new onset ventricular and/or atrial arrhythmias during the first 48 hours after randomization, Left ventricular outflow tract velocity time integral (LVOT VTI), ejection fraction (EF), tricuspid annular plane systolic excursion (TAPSE) at baseline, 24 and 48 hours after randomization, Cardiac output, pulmonary capillary wedge pressure, central venous pressure (measured by pulmonary artery catheter), SVO2 at baseline, 24 and 48 hours after randomization, Lactate level at baseline, 24 and 48 hours after randomization, Troponin at 24 and 48 hours after randomization and Area Under the Curve (AUC), Myocardial oxygen consumption estimated by calculating the pressure volume (PV) area on basis of non-invasive PV loop assessments using ech

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026