Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT06522594
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06522594
Study Brief:
Protocol Section:
NCT06522594