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.
Despite the great benefits of Venoarterial ExtraCorporeal Membrane Oxygenation (V-A ECMO) and its rapidly increasing usage, even today, 30 till 70 percent of patients cannot be weaned from ECMO support and up to 50 percent of patients will eventually die in the first year. These high incidences of mortality and failure to wean from V-A ECMO support seem largely attributable to failure of the heart to recover in the context of inotropic drug administration and high sympathetic drive due to severe illness (further stressing an already failing heart). As V-A ECMO support creates a "safety window" where organ perfusion no longer relies on native cardiac output, therapeutic focus could be shifted to cardioprotective treatments. Cardioprotective treatments typically include beta blockers (BB) which have unequivocally shown benefits on mortality and morbidity in other patient categories with heart failure with reduced ejection fraction (HFrEF). The investigators hypothesize that, in selected patients with cardiogenic shock undergoing V-A ECMO support, application of BBs is feasible and safe, and can effectively reduce heart rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A vey cardioselective, short-acting betablocker, with an ultra-short half life time.
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
RECRUITINGChange (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).
Time frame: 24 hours after randomization
Percentage of patients having received esmolol
Time frame: after 48 hours
Vasopressor score
using the calculation as described in literature, excluding inotropic medication
Time frame: at baseline, 24 and 48 hours
Occurrence of new onset ventricular and/or atrial arrhythmias after randomization
Time frame: during the first 48 hours
Left ventricular outflow tract velocity time integral (LVOT VTI)
Echocardiography parameters
Time frame: at baseline, 24 and 48 hours
Cardiac output
Pulmonary arterial catheter parameter
Time frame: at baseline, 24 and 48 hours
Stroke volume index
Pulmonary arterial catheter parameter
Time frame: at baseline, 24 and 48 hours
Pulmonary capillary wedge pressure
Pulmonary arterial catheter parameter
Time frame: at baseline, 24 and 48 hours
Central venous pressure
Pulmonary arterial catheter parameter
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Time frame: at baseline, 24 and 48 hours
Mixed venous oxygen saturation (SvO2)
Pulmonary arterial catheter parameter
Time frame: at baseline, 24 and 48 hours
Lactate level
Time frame: at baseline, 24 and 48 hours
Troponin
measured at baseline, 24- and 48- hours after randomization, and Area Under the Curve (AUC)
Time frame: 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
Time frame: At 24 and 48 hours after randomization
Plasma NT-proBNP levels
Biomarker for cardiac stretch
Time frame: At baseline and 48 hours after randomization
Plasma Creatine Kinase MB levels
Biomarker for cardiac injury
Time frame: At baseline and 48 hours after randomization
FiO2 suppletion
Time frame: At 24 and 48 hours after randomization
Plasma metanephrine levels
Time frame: At baseline and 24 after randomization
Plasma normetanephrines levels
Time frame: At baseline and 24 after randomization
Maximum median dosages of esmolol
Time frame: after 48 hours
Ejection fraction (EF)
Echocardiography parameters
Time frame: at baseline, 24 and 48 hours
Tricuspid annular plane systolic excursion (TAPSE).
Echocardiography parameters
Time frame: at baseline, 24 and 48 hours
Positive End Expiratory Pressure (PEEP) level
Time frame: At 24 and 48 hours after randomization