1. Extra corporeal membrane oxygenation in the therapy of cardiogenic shock (ECMO-CS): rationale and design of the multicenter randomized trial
- Author
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Ondrej Smid, Jan Bělohlávek, Aleš Linhart, Milan Hromádka, Richard Rokyta, Marek Janotka, Dagmar Vondrakova, Petr Ostadal, Andreas Krüger, and Jana Smalcova
- Subjects
medicine.medical_specialty ,business.industry ,Cardiogenic shock ,medicine.medical_treatment ,Percutaneous coronary intervention ,030208 emergency & critical care medicine ,030204 cardiovascular system & hematology ,medicine.disease ,Cardiac surgery ,law.invention ,Clinical trial ,03 medical and health sciences ,surgical procedures, operative ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Heart failure ,medicine ,Cardiology ,Extracorporeal membrane oxygenation ,Clinical endpoint ,Cardiology and Cardiovascular Medicine ,business - Abstract
Aims Extracorporeal membrane oxygenation (ECMO) in veno-arterial configuration represents an increasingly used method for circulatory support. ECMO in cardiogenic shock offers rapid improvement of circulatory status and significant increase in tissue perfusion. Current evidence on the use of ECMO in cardiogenic shock remains insufficient. The aim of the ECMO-CS trial is to compare two recognized therapeutic approaches in the management of severe cardiogenic shock: early conservative therapy and early implantation of veno-arterial ECMO on the background of standard care. Methods Eligible patients have either rapidly deteriorating or severe cardiogenic shock, defined using echocardiography, hemodynamic and metabolic criteria. Patients are randomized to the one of two arms: immediate veno-arterial ECMO therapy or early conservative therapy. All other diagnostic and therapeutic procedures are performed as per current standard of care, including other cardiovascular interventions (i.e. percutaneous coronary intervention or cardiac surgery). Follow-up includes visits at 30 days, 6 months and 12 months. Primary endpoint is a composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device at 30 days. The sample size of 120 individuals (60 in each arm) provides 80% power to detect 50% reduction of primary endpoint, at alpha = 0.05. Patient recruitment started in October 2014. Conclusion The results of the ECMO-CS trial may significantly influence current practice in the management of patients with severe and rapidly deteriorating cardiogenic shock. ECMO-CS trial registration number is NCT02301819.
- Published
- 2017