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SAVE-J NEUROTHERM trial

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1060240086
Enrollment
468
Registered
2024-12-05
Start date
2025-01-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OHCA patients receiving ECPR Out-of-Hospital Cardiac Arrest

Interventions

- Hypothermia group: Ttemperature control at 33-34 degree Celsius - Normothermia group: Ttemperature control at 36 degree Celsius
D001831

Sponsors

Inoue Akihiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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Concomitant illness such as malignancy shortens life expectancy (180 day survival unlikely) 16) Consent not obtained or withdrawn by the participant or surrogate 17) Other reasons, physician decision not to enroll

Design outcomes

Primary

MeasureTime frame
Survival at hospital discharge

Secondary

MeasureTime frame
- 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

Countries

Japan, Taiwan

Contacts

Public ContactYoko Kataoka

Kagawa University Hospital

j-neuro@googlegroups.com+81-87-891-5677

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026