Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest
Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest: A Cluster Randomized Trial (SAVE-J NEUROTHERM Trial)
Kagawa University
468 participants
Jan 6, 2025
INTERVENTIONAL
Conditions
Summary
The SAVE-J NEUROTHERM trial is a cluster randomized trial that evaluated and compared the mortality risk, neurological outcomes, and adverse events between patients who underwent hypothermia and those who underwent normothermia after extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest.
Eligibility
Inclusion Criteria3
- 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 Criteria17
- 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- Consent not obtained or withdrawn by the participant or surrogate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
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Interventions
Procedure: Temperature control at 33-34 °C In the hypothermia group, patients receiving ECPR will be immediately cooled to 33ºC-34ºC with ECMO using a heat exchanger. After reaching this targeted temperature, the maintenance phase will start, and the target temperature will be kept at 33ºC-34°C. The maintenance phase will end 24 h after reaching this targeted temperature. Subsequently, rewarming to 36ºC-37ºC will be conducted in 24 h. After the rewarming, the temperature will be kept in the range of 36ºC-37.5ºC for 24 h after rewarming or until the end of ECMO, and should not exceed 37.5ºC. Other interventions, such as sedation, administration of neuromuscular blocking agents, antipyretics, and catecholamines, as well as mechanical circulatory support, are optional and performed at the patient's discretion.
Procedure: Temperature control at 36 °C In the normothermia group receiving ECPR, the temperature of 36ºC will be immediately reached with ECMO using a heat exchanger. After reaching this targeted temperature, the maintenance phase will start, and the target temperature will be maintained at 36ºC. The maintenance phase will end 24 h after reaching this targeted temperature. Then, rewarming to 36ºC-37ºC will be conducted in 24 h. After the rewarming, the temperature will be kept in the range of 36ºC-37.5ºC for 24 h after rewarming or until the end of ECMO, and should not exceed 37.5ºC. Other interventions, such as sedation, administration of neuromuscular blocking agents, antipyretics, and catecholamines, as well as mechanical circulatory support, are optional and performed at the patient's discretion.
Locations(28)
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NCT06776549