TAME cardiac arrest: A phase III multicenter randomized trial of targeted therapeutic mild hypercapnia after resuscitated cardiac arrest

Abstract

Cardiac arrest (CA) is a catastrophic world-wide health problem with substantial human and financial costs. Ongoing cerebral vasoconstriction and cerebral hypoxia during the early post-resuscitation period may contribute to the often poor neurological outcome in CA survivors. Arterial carbon dioxide (PaCO2) is the major determinant of cerebral blood flow and an increased PaCO2 (hypercapnia) markedly increases cerebral blood flow and oxygenation. This paper reports on the background and method of The TAME Cardiac Arrest trial (Clinicaltrials.gov (NCT03114033) which is a phase III multi-center, randomized, parallel-group, controlled trial. The trial will determine if targeted therapeutic mild hypercapnia (TTMH) (PaCO250-55mmHg) during mechanical ventilation improves neurological outcome at 6 months compared to targeted normocapnia (TN) (PaCO235-45 mmHg) in resuscitated CA patients. The intervention is cost-free and will be applied over the first 24-hours of ICU care. A total of 1700 adult resuscitated CA patients from ICUs around the world will be enrolled. When completed the TAME Cardiac Arrest trial will provide unprecedented insights that will transform the care of resuscitated CA patients admitted to the intensive care unit (ICU) around the world. Moreover, this therapy is cost free and, if shown to be effective, will improve thousands of lives, transform clinical practice, and yield major financial savings.