REMAP ECMO - Beta Receptor Modulation Trial
Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation - Beta Receptor Modulation Trial
Erasmus Medical Center
20 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
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 Criteria6
- 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 Criteria18
- 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
Interventions
A vey cardioselective, short-acting betablocker, with an ultra-short half life time.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06522594