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

Last updated: June 26, 2025
Sponsor: Kagawa University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Temperature control

Clinical Study ID

NCT06776549
j-neuro
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • OHCA

  • Age of 18-75 years, known or estimated

  • An initial cardiac arrest rhythm of ventricular fibrillation/pulseless ventriculartachycardia or pulseless electrical activity

Exclusion

Exclusion Criteria:

  • ECMO initiated after sustained return of spontaneous circulation (ROSC) and patientswith 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 forthe 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 survivalunlikely)

  • Consent not obtained or withdrawn by the participant or surrogate

  • Other reasons, physician's decision not to enroll the patient

Study Design

Total Participants: 468
Treatment Group(s): 1
Primary Treatment: Temperature control
Phase:
Study Start date:
January 06, 2025
Estimated Completion Date:
December 31, 2028

Study Description

Temperature control is a key neurointensive care for post-cardiac arrest patients. Although therapeutic hypothermia has been shown to be effective in the past, recent large randomized controlled trials have failed to demonstrate its efficacy. The international guidelines recommend temperature control under 37.7°C. However, the optimal temperature control, i.e., hypothermia versus normothermia, remains controversial. Additionally, randomized controlled trials that examined temperature control after extracorporeal cardiopulmonary resuscitation (ECPR) are lacking.

ECPR is a resuscitation technique using extracorporeal membrane oxygenation (ECMO) for refractory cardiac arrest. In ECPR patients, ECMO using a heat exchanger can more rapidly achieve the targeted temperature as compared to other temperature control devices. Early cooling to achieve hypothermia after resuscitation is expected to be more effective for neuroprotection in the injured brain. Thus, the investigators hypothesized that hypothermia would be effective in ECPR patients.

Furthermore, ECMO can stabilize the respiratory and circulatory status. Therefore, hypothermia, which may have side effects such as electrolyte abnormalities and arrhythmias, may be safely performed by ECMO. However, ECMO requires the administration of anticoagulants; therefore, it has the risk of hemorrhagic complications. Among patients receiving ECPR, bleeding is a common complication due to its relatively difficult procedure, considering the fact that emergent cannulation is performed under resuscitation. Additionally, CPR-related complications can also result in bleeding. These complications may be enhanced by hypothermia. Therefore, hypothermia after ECPR could contribute to a favorable outcome, but it could also cause bleeding.

The SAVE-J NEUROTHERM trial is a cluster randomized trial that evaluated and compared the mortality risk, neurological outcomes, and adverse events between out-of-hospital cardiac arrest (OHCA) patients who underwent hypothermia and normothermia after ECPR.

Connect with a study center

  • Kurume University Hospital

    Kurume, Fukuoka 8300011
    Japan

    Active - Recruiting

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaido 0788510
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, Hokkaido 0608648
    Japan

    Active - Recruiting

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido 0608556
    Japan

    Active - Recruiting

  • Hyogo Prefectural Kakogawa Medical Center

    Kakogawa, Hyogo 6758555
    Japan

    Active - Recruiting

  • Hyogo Emergency Medical Center

    Kobe, Hyogo 6510073
    Japan

    Active - Recruiting

  • Toyooka Public Hospital

    Toyooka, Hyogo 6688501
    Japan

    Active - Recruiting

  • Kagawa University Hospital

    Kita-gun, Kagawa 7610793
    Japan

    Active - Recruiting

  • Oshima Prefectural Hospital

    Amami, Kagoshima 8940015
    Japan

    Active - Recruiting

  • Oshima Prefectural Hospital

    Oshima, Kagoshima
    Japan

    Site Not Available

  • Ebina General Hospital

    Ebina, Kanagawa 2430432
    Japan

    Active - Recruiting

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, Kanagawa 2308765
    Japan

    Active - Recruiting

  • Sendai Medical Center

    Sendai, Miyagi 9838520
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi 9808574
    Japan

    Active - Recruiting

  • Tsuyama Chuo Hospital

    Tsuyama, Okayama 7080841
    Japan

    Active - Recruiting

  • Okinawa Prefectural Nanbu Medical Center & Children's Medical Center

    Shimajiri-gun, Okinawa 9011193
    Japan

    Active - Recruiting

  • Osaka Saiseikai Senri Hospital

    Suita, Osaka 5650862
    Japan

    Active - Recruiting

  • Japanese Red Cross Musashino Hospital

    Musashino, Tokyo
    Japan

    Site Not Available

  • National Hospital Organization Disaster Medical Center

    Tachikawa, Tokyo
    Japan

    Site Not Available

  • Kagawa University Hospital

    Kagawa,
    Japan

    Site Not Available

  • Kyoto Second Red Cross Hospital

    Kyoto, 6028026
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, 7008558
    Japan

    Active - Recruiting

  • Okinawa Prefectural Nanbu Medical Center & Children's Medical Center

    Okinawa,
    Japan

    Site Not Available

  • Saitama Red Cross Hospital

    Saitama, 3308553
    Japan

    Active - Recruiting

  • Institute of Science Tokyo Hospital

    Tokyo, 1138519
    Japan

    Active - Recruiting

  • Japanese Red Cross Musashino Hospital

    Tokyo, 1808610
    Japan

    Active - Recruiting

  • Keio University Hospital

    Tokyo, 1608582
    Japan

    Active - Recruiting

  • National Hospital Organization Disaster Medical Center

    Tokyo, 1900014
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital

    Tokyo, 1138603
    Japan

    Active - Recruiting

  • St. Luke's International Hospital

    Tokyo, 1048560
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Bokutoh Hospital

    Tokyo, 1308575
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Tama Medical Center

    Tokyo, 1838524
    Japan

    Active - Recruiting

  • Tottori Prefectural Central Hospital

    Tottori, 6800901
    Japan

    Active - Recruiting

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