Most patients who suffer a cardiac arrest do not survive. Over the past 20 years, one of the few promising therapies for patients who have regained Return of Spontaneous Circulation (ROSC) after cardiac arrest is controlling the body temperature (Targeted Temperature Management or TTM). However, much remains unknown about TTM, including the ideal temperature to maintain and how long to maintain it.
ICECAP (Influence of Cooling duration on Efficacy in Cardiac Arrest Patients) aims to answer the question of how long to maintain hypothermic temperature control. ICECAP is enrolling adult patients who have suffered an out-of-hospital cardiac arrest and who are undergoing TTM at 33˚C. Patients are eligible if they have ROSC in the emergency department and their body temperature is brought < 34˚C within four hours of their arrest. Once enrolled, the patients are randomized to a duration of maintaining 33˚C body temperature. Possible durations are between six hours and 72 hours.
ICECAP has an adaptive design, so that patients will preferentially be randomized to durations of cooling that appear most likely to be beneficial based on the results of previous enrollees. Care outside of TTM duration will be unaffected by ICECAP and care is dictated by the primary intensive care team. Whenever possible, patients are to continue to receive maximal support and the best chance for neurologic recovery for at least five days, to avoid premature discontinuation of life saving therapies due to premature neuro-prognostication, which has been shown to be unreliable in the early days after cardiac arrest.
Patients are excluded for severe hemodynamic instability, pre-existing terminal illness, planned early withdrawal of life support, or sepsis as cause of arrest. To enroll a patient in ICECAP, a family member or legally authorized representative must consent to their participation, and this consent must be completed within six hours of TTM. Patients are followed throughout their hospital course and a 30 day cognitive assessment and modified ranking score is performed on survivors.