REMAP ECMO - Beta Receptor Modulation Trial

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.

Eligibility

Inclusion Criteria:

* 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 ≥ 80 bpm (being sinus rhythm, atrial fibrillation or atrial flutter) after V-A ECMO initiation

Exclusion Criteria:

* Objection during the deferred consent procedure
* V-A ECMO usage confined to the period during surgery or another intervention (the ECMO was removed at the end of the intervention).
* Concomitant durable Left Ventricular Assist Device (LVAD)
* Polymorphic ventricular tachycardia necessitating BB 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 intra-aortic balloon pump (IABP) standby)
  * Spontaneous contrast in the heart at echocardiography
* Contraindications for-, intolerance to- or allergy to esmolol
* Second- or third- degree AV block
* Pregnancy
* Life expectancy of less than 24 hours
* Participation in another randomized clinical trial (e.g. On Scene trial or Left Ventricular unloading trial)
* Inability to start study treatment within 4 hours after randomization
* Post heart transplantation patients

Conditions3

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