Status:
RECRUITING
REMAP ECMO - Beta Receptor Modulation Trial
Lead Sponsor:
Erasmus Medical Center
Conditions:
Heart Failure
Cardiogenic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 dos...
Detailed Description
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 suppor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 3 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06522594
Start Date
June 1 2024
End Date
December 3 2025
Last Update
July 26 2024
Active Locations (1)
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1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015GD