Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest

Launched by KAGAWA UNIVERSITY · Jan 14, 2025

Keywords

ClinConnect Summary

The SAVE-J NEUROTHERM trial is studying how different temperature treatments—hypothermia (cooling the body) versus normothermia (keeping the body at normal temperature)—affect patients who have experienced a sudden cardiac arrest outside of the hospital and received a life-saving procedure called extracorporeal cardiopulmonary resuscitation (ECPR). Researchers want to find out which approach can help reduce the risk of death and improve brain function after such an event.

To participate in this trial, potential volunteers should be between 18 and 75 years old and have had an out-of-hospital cardiac arrest, specifically with certain heart rhythms that make the situation critical. However, there are some conditions that would exclude someone from joining, such as if their heart started beating again before receiving ECPR or if they have certain other health issues. Participants in the trial will be monitored closely to see how well they respond to the different temperature treatments, and their outcomes will help guide future care for patients in similar situations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • OHCA
• • Age of 18-75 years, known or estimated
• • An initial cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia or pulseless electrical activity
• Exclusion Criteria:
• • ECMO initiated after sustained return of spontaneous circulation (ROSC) and patients with sustained ROSC before ECMO initiation
• • OHCA of presumed non-cardiac etiology
• • Time from emergency call or witnessed arrest to hospital arrival of \>60 min
• • Time from hospital arrival to ECMO initiation of \>60 min
• • Pre-hospital ECPR
• • Unavailability of the ECMO heat exchanger for temperature control
• • Glasgow Coma Scale score before temperature control of \>8
• • Core body temperature upon hospital arrival of ≤32ºC
• • Surgical intervention before temperature control (e.g., surgical intervention for the primary disease or complications related to resuscitation/ECMO procedures)
• • Do Not Attempt Resuscitation) order confirmed prior to temperature control
• • Limitations in intensive care before temperature control
• • Known cerebral performance category (CPC) of 3-4 before cardiac arrest
• • Known chronic obstructive pulmonary disease with home oxygen therapy
• • Known or suspected pregnancy
• • Concomitant illness, such as malignancy, shortens life expectancy (180-day survival unlikely)
• • Consent not obtained or withdrawn by the participant or surrogate
• • Other reasons, physician's decision not to enroll the patient