ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock

Study Overview
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Brief Summary
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Eligible patients with severe cardiogenic shock will be randomized to one of the two arms: immediate ECMO therapy or early conservative therapy. In the invasive group, veno-arterial ECMO will be implanted according to the local practice with flow settings to ensure sufficient tissue perfusion. With the exception of ECMO implantation in the invasive group, all other diagnostic and therapeutic procedures will be done according to the current standard of care at the tertiary cardiovascular center, including other cardiovascular interventions (i.e. percutaneous coronary intervention or cardiac surgery). Implantation of other mechanical support devices including ECMO in the primary conservative group is allowed in the case of shock progression with rise of serum lactate by 3 mmol/L in comparison with the lowest value during the past 24 hours. Follow-up include visits at 30 days, 6 moths and 12 months.

Official Title
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ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Device: Veno-arterial extracorporeal membrane oxygenation (ECMO)
* Other: Early conservative therapy according to standard practice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must fulfil criteria for rapidly deteriorating (A) or severe (B) cardiogenic shock: A. Rapidly deteriorating cardiogenic shock is defined as progressive hemodynamic instability necessitating repeated bolus administration of vasopressors to maintain mean arterial pressure > 50 mmHg + impaired left ventricle systolic function (Left ventricle ejection fraction (LVEF) < 35% or LVEF 35-55% in case of severe mitral regurgitation or aortic stenosis) or B. In severe cardiogenic shock all following criteria should be met: Hemodynamic: Cardiac Index (CI) < 2.2 L/min/m2 + norepinephrine dose > 0.1 μg/kg/min + dobutamin dose > 5 μg/kg/min or Systolic blood pressure < 100 mmHg + norepinephrine dose > 0.2 μg/kg/min + dobutamin dose > 5 μg/kg/min + (LVEF < 35% or LVEF 35-55% + severe mitral regurgitation or aortic stenosis) Metabolic: Lactate - two consecutive values ≥ 3 mmol/L (with at least 30 min between samples), with non-decreasing trend on steady doses of inotropes and/or vasopressors or SvO2 - two consecutive values < 50% (with at least 30 min between measurements), with non-increasing trend on steady doses of inotropes and/or vasopressors Hypovolemia must be excluded: Central venous pressure > 7 mmHg or pulmonary capillary wedge pressure > 12 mmHg Exclusion Criteria: Age < 18 years Life expectancy lower than 1 year High suspicion of pulmonary emboli or cardiac tamponade as a cause of shock Significant bradycardia or tachycardia which might be responsible for hemodynamic instability and not treated by pacing or cardioversion Cardiac arrest survivors remaining comatose Hypertrophic obstructive cardiomyopathy Peripheral artery disease disabling insertion of outflow cannula to femoral artery Moderate to severe aortic regurgitation Aortic dissection Uncontrolled bleeding or TIMI major bleeding within last 6 months Known encephalopathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Invasive<br>Immediate veno-arterial extracorporeal membrane oxygenation (ECMO) | Device: Veno-arterial extracorporeal membrane oxygenation (ECMO)<br>* Veno-arterial extracorporeal membrane oxygenation (ECMO) will be ineserted as soon as possible and set to achieve adequate organ and tissue perfusion.<br>|
| Active Comparator: Conservative<br>Early conservative therapy according to standard practice | Other: Early conservative therapy according to standard practice<br>* Standard therapy including inotropes and vasopressors will be used to achieve hemodynamic stabilization and adequate tissue perfusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 30 days | 
| All-cause mortality |  | 6 months | 
| All-cause mortality |  | 12 months | 
| Neurological outcome (according to Cerebral Performance Category scale) |  | 30 days |