Current and future trial design in refractory cardiogenic shock.

Abstract

Cardiogenic shock is a life-threatening syndrome of peripheral hypoperfusion and organ dysfunction due to primary cardiac disease. Few adequately designed randomized clinical trials provide guidance on the optimal management strategies, which frequently includes vasoactive drugs, circulatory and ventilatory support, and reversal of any underlying cause, including coronary revascularization in case of acute myocardial infarction. Management is largely based on experience rather than evidence-based recommendations and patient outcomes remain poor. Particular attention is currently given to refractory patients (i.e., not responding to medical treatment) with a growing number of studies investigating various modalities of mechanical circulatory support. This consensus document summarizes the output from the third Critical Care Clinical Trialists Workshop, where a group of experts convened to discuss, debate, and reflect on approaches related to trials in refractory cardiogenic shock, to provide recommendations for the design of future trials. Invited participants included clinical trialists, clinicians (including cardiologists, intensive care specialists, anaesthesiologists, and cardiac surgeons), epidemiologists, patient representatives, regulators from the United States and Europe, United States federal grant managers, and industry representatives. Special attention is given to current and future definitions of cardiogenic shock including refractory states, recent and ongoing clinical trials in refractory cardiogenic shock and future directions in light of the most recent literature.