Beta receptor modulation trial in cardiogenic shock patients supported by V-A ECMO
- Conditions
- Cardiogenic shockTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Age = 18 years, Having received V-A ECMO support for severe circulatory insufficiency due to left- or bi-ventricular failure, = 16 hours after initiation of V-A ECMO support, Receiving = 2 mcg/kg/min of dobutamine, Norepinephrine infusion = 0.4 mcg/kg/min, Heart rate of = 80 bpm (being sinus rhythm, atrial fibrillation or atrial flutter) after V-A ECMO initiation
Objection during the deferred consent procedure, Second- or third- degree AV block, Pregnancy, Estimated life expectancy of < 24 hours, Participation in another randomized clinical trial, Inability to start study treatment within 4 hours after randomization, Post heart transplantation patients, V-A ECMO usage confined to the period during surgery or another intervention (the ECMO was removed at the end of the intervention), Concomittant durable LVAD, Polymorphic ventricular tachycardia necessitating betablocker therapy, Isolated right ventricular failure (e.g. due to pulmonary embolism), Need of high dose dobutamine > 6.0 mcg/kg/min, Epinephrine infusion, Signs of insufficient trans cardiac flow (Absence of aortic valve opening, pulse pressure <10 mmHg (with IABP standby), spontaneous contrast in the heart at echocardiography), Contraindications for-, intolerance to- or allergy to esmolol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To demonstrate safety and feasibility of a strategy involving a reduction in BR stimulation and subsequent inhibition through application of an intravenous BB (BR inhibition).<br>2. To study the effect of a beta receptor inhibition strategy versus a strategy to continue beta receptor stimulation (as is done in routine clinical care) on heart rate.;Secondary Objective: To study the effect of a strategy involving a reduction and subsequent inhibition of the BR versus a strategy to continue BR stimulation (as is routine care at this moment) on myocardial oxygen consumption, cardiac function, and cardiac markers.;Primary end point(s): Change (delta) in heart rate 24 hours after randomization. The average heart rate will be calculated based on all observations during 5 minutes.
- Secondary Outcome Measures
Name Time Method