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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
122
Veno-arterial extracorporeal membrane oxygenation (ECMO) will be ineserted as soon as possible and set to achieve adequate organ and tissue perfusion.
Standard therapy including inotropes and vasopressors will be used to achieve hemodynamic stabilization and adequate tissue perfusion.
Na Homolce Hospital
Prague, Select One, Czechia
Regional Hospital Liberec
Liberec, Czechia
University Hospital Pilsen
Pilsen, Czechia
General University Hospital
Prague, Czechia
Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device
Time frame: 30 days
All-cause mortality
Time frame: 30 days
All-cause mortality
Time frame: 6 months
All-cause mortality
Time frame: 12 months
Neurological outcome (according to Cerebral Performance Category scale)
Time frame: 30 days
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