SAVE-J NEUROTHERM trial

JRCT ID: jRCT1060240086

Registered date:05/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: OHCA patients receiving ECPR
• Date of first enrollment: 06/01/2025
• Target sample size: 468
• Study type: Interventional

Intervention(s)

- Hypothermia group: Ttemperature control at 33-34 degree Celsius
- Normothermia group: Ttemperature control at 36 degree Celsius

Outcome(s)

• Primary Outcome: Survival at hospital discharge

Secondary Outcome

- Survival at 30 days, 90 days, and one year after admission
- Cerebral Performance Category (CPC) at hospital discharge, 30 days, 90 days, and one year after admission
- Serious adverse events (arrhythmia, bleeding, pneumonia, bacteremia) during ICU

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Out-of-hospital cardiac arrest
2) Age of 18-75 years, known or as estimated
3) Initial cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia or pulseless electrical activity

Exclude criteria

1) ECMO initiated after sustained return of spontaneous circulation (ROSC), patients with sustained ROSC before ECMO initiation
2) OHCA of presumed non-cardiac etiology
3) Time from emergency call or witnessed arrest to hospital arrival > 60 minutes
4) Time from hospital arrival to ECMO initiation > 60 minutes
5) Prehospital ECPR
6) Unavailability of the ECMO heat exchanger for temperature control
7) Glasgow Coma Scale (GCS) before temperature control >8
8) Core body temperature upon hospital arrival under 32 degrees Celsius
9) Surgical intervention before temperature control (e.g., surgical intervention for the primary disease or complications related to resuscitation/ECMO procedures)
10) Do Not Attempt Resuscitation (DNAR) order confirmed prior to temperature control
11) Limitations in intensive care before temperature control
12) Known cerebral performance category (CPC) of 3-4 before cardiac arrest
13) Known chronic obstructive pulmonary disease with home oxygen therapy
14) Known or as estimated pregnancy
15) Concomitant illness such as malignancy shortens life expectancy (180 day survival unlikely)
16) Consent not obtained or withdrawn by the participant or surrogate
17) Other reasons, physician decision not to enroll

Related Information

• Primary Sponsor: Inoue Akihiko
• Source(s) of Monetary Support: Terumo Corporation,Senko Medical Instruments, Mfg., Co., Ltd.