REMAP ECMO - Beta Receptor Modulation Trial
NCT Number: NCT06522594
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Heart Failure|Cardiogenic Shock
Interventions: DRUG: Esmolol
Sponsor: Erasmus Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-12-03
Locations: Erasmus Medical Center, Rotterdam, Zuid Holland, 3015GD, Netherlands

Summary:
In this phase 2, single center, randomized clinical pilot trial, investigators will study the effect of a strategy involving a reduction of beta receptor (BR) stimulation (by decreasing dobutamine dosages) and subsequent BR inhibition (through ultra-short acting betablockers), versus a (routine) strategy with continued BR stimulation through dobutamine infusion, on heart rate in patients with cardiogenic shock due to left- or bi-ventricular failure being supported by V-A ECMO.

Primary Outcome Measures: Change (delta) in heart rate 24 hours after randomization., The average heart rate on basis of all observations during 5 minutes at both time points (t=0 and t=24h)., 24 hours after randomization
Secondary Outcome Measures: Percentage of patients having received esmolol, after 48 hours|Vasopressor score, using the calculation as described in literature, excluding inotropic medication, at baseline, 24 and 48 hours|Occurrence of new onset ventricular and/or atrial arrhythmias after randomization, during the first 48 hours|Left ventricular outflow tract velocity time integral (LVOT VTI), Echocardiography parameters, at baseline, 24 and 48 hours|Cardiac output, Pulmonary arterial catheter parameter, at baseline, 24 and 48 hours|Stroke volume index, Pulmonary arterial catheter parameter, at baseline, 24 and 48 hours|Pulmonary capillary wedge pressure, Pulmonary arterial catheter parameter, at baseline, 24 and 48 hours|Central venous pressure, Pulmonary arterial catheter parameter, at baseline, 24 and 48 hours|Mixed venous oxygen saturation (SvO2), Pulmonary arterial catheter parameter, at baseline, 24 and 48 hours|Lactate level, at baseline, 24 and 48 hours|Troponin, measured at baseline, 24- and 48- hours after randomization, and Area Under the Curve (AUC), At 24 and 48 hours after randomization|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|Plasma NT-proBNP levels, Biomarker for cardiac stretch, At baseline and 48 hours after randomization|Plasma Creatine Kinase MB levels, Biomarker for cardiac injury, At baseline and 48 hours after randomization|FiO2 suppletion, At 24 and 48 hours after randomization|Plasma metanephrine levels, At baseline and 24 after randomization|Plasma normetanephrines levels, At baseline and 24 after randomization|Maximum median dosages of esmolol, after 48 hours|Ejection fraction (EF), Echocardiography parameters, at baseline, 24 and 48 hours|Tricuspid annular plane systolic excursion (TAPSE)., Echocardiography parameters, at baseline, 24 and 48 hours|Positive End Expiratory Pressure (PEEP) level, At 24 and 48 hours after randomization