Status:
COMPLETED
ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock
Lead Sponsor:
Na Homolce Hospital
Collaborating Sponsors:
General University Hospital, Prague
University Hospital Pilsen
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 impla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT02301819
Start Date
September 1 2014
End Date
January 1 2023
Last Update
April 5 2023
Active Locations (4)
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1
Na Homolce Hospital
Prague, Select One, Czechia, 15030
2
Regional Hospital Liberec
Liberec, Czechia
3
University Hospital Pilsen
Pilsen, Czechia, 30460
4
General University Hospital
Prague, Czechia, 12808