• Eur. J. Heart Fail. · May 2017

    Randomized Controlled Trial Multicenter Study

    Extra corporeal membrane oxygenation in the therapy of cardiogenic shock (ECMO-CS): rationale and design of the multicenter randomized trial.

    • Petr Ostadal, Richard Rokyta, Andreas Kruger, Dagmar Vondrakova, Marek Janotka, Ondrej Smíd, Jana Smalcova, Milan Hromadka, Ales Linhart, and Jan Bělohlávek.
    • Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.
    • Eur. J. Heart Fail. 2017 May 1; 19 Suppl 2: 124-127.

    AimsExtracorporeal 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.MethodsEligible 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.ConclusionThe 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.© 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

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