臨床研究等提出・公開システム

Hypothermia versus normothermia after extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest: A cluster randomized trial (SAVE-J NEUROTHERM trial)

SAVE-J NEUROTHERM trial

Inoue Akihiko

Kagawa University Hospital

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa

a-inoue@hemc.jp

Kataoka Yoko

Kagawa University Hospital

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa

+81-87-891-5677

j-neuro@googlegroups.com

Recruiting

Jan. 06, 2025

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

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

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16) Consent not obtained or withdrawn by the participant or surrogate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

Both

OHCA patients receiving ECPR

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

Out-of-Hospital Cardiac Arrest

Temperature control

D058687

D001831

Survival at hospital discharge

- 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

+81-87-891-2011

July. 24, 2023

No

Taiwan