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

NCT06776549 | Recruiting

• 1 other identifier: j-neuro
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 28

Brief 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.

Conditions

Out-of-hospital Cardiac Arrest (OHCA); ECMO Treatment; Temperature; Post Cardiac Arrest Syndrome

Keywords

Cardiac arrest; Out-of-hospital cardiac arrest (OHCA); Extracorporeal cardiopulmonary resuscitation (ECPR); Temperature control; Post cardiac arrest syndrome (PCAS)

Outcome Measures

Primary Outcomes (1)

• Survival

  At discharge (approximately 25 days)

Secondary Outcomes (3)

• Survival

  At 30 days, 90 days, and 1 year after admission

• Neurological function: Cerebral performance categories (CPC)

  At discharge (approximately 25 days), 30 days, 90 days, and 1 year after admission

• Adverse events

  During the intensive care unit stay, an average of 2 weeks

Study Arms (2)

Normothermia

ACTIVE COMPARATOR

Temperature control at 36 °C

Procedure: Temperature control

Hypothermia

EXPERIMENTAL

Temperature control at 33-34 °C

Procedure: Temperature control

Interventions

Temperature control PROCEDURE

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.

Hypothermia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OHCA
• Age of 18-75 years, known or estimated
• An initial cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia or pulseless electrical activity

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kagawa University: lead

Study Sites (28)

Kurume University Hospital

Kurume, Fukuoka, 8300011, Japan

RECRUITING

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, 0788510, Japan

NOT YET RECRUITING

Sapporo Medical University Hospital

Sapporo, Hokkaido, 0608556, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, 0608648, Japan

RECRUITING

Hyogo Prefectural Kakogawa Medical Center

Kakogawa, Hyōgo, 6758555, Japan

RECRUITING

Hyogo Emergency Medical Center

Kobe, Hyōgo, 6510073, Japan

RECRUITING

Toyooka Public Hospital

Toyooka, Hyōgo, 6688501, Japan

RECRUITING

Kagawa University Hospital

Kita-gun, Kagawa-ken, 7610793, Japan

RECRUITING

Oshima Prefectural Hospital

Amami, Kagoshima-ken, 8940015, Japan

RECRUITING

Ebina General Hospital

Ebina, Kanagawa, 2430432, Japan

RECRUITING

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, 2308765, Japan

RECRUITING

Kyoto Second Red Cross Hospital

Kyoto, Kyoto, 6028026, Japan

NOT YET RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 9808574, Japan

RECRUITING

Sendai Medical Center

Sendai, Miyagi, 9838520, Japan

RECRUITING

Okayama University Hospital

Okayama, Okayama-ken, 7008558, Japan

RECRUITING

Tsuyama Chuo Hospital

Tsuyama, Okayama-ken, 7080841, Japan

RECRUITING

Okinawa Prefectural Nanbu Medical Center & Children's Medical Center

Shimajiri-gun, Okinawa, 9011193, Japan

RECRUITING

Osaka Saiseikai Senri Hospital

Suita, Osaka, 5650862, Japan

RECRUITING

Saitama Red Cross Hospital

Saitama, Saitama, 3308553, Japan

RECRUITING

Tottori Prefectural Central Hospital

Tottori-shi, Tottori, 6800901, Japan

RECRUITING

St. Luke's International Hospital

Tokyo, 1048560, Japan

RECRUITING

Institute of Science Tokyo Hospital

Tokyo, 1138519, Japan

RECRUITING

Nippon Medical School Hospital

Tokyo, 1138603, Japan

RECRUITING

Tokyo Metropolitan Bokutoh Hospital

Tokyo, 1308575, Japan

RECRUITING

Keio University Hospital

Tokyo, 1608582, Japan

RECRUITING

Japanese Red Cross Musashino Hospital

Tokyo, 1808610, Japan

RECRUITING

Tokyo Metropolitan Tama Medical Center

Tokyo, 1838524, Japan

RECRUITING

National Hospital Organization Disaster Medical Center

Tokyo, 1900014, Japan

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Post-Cardiac Arrest Syndrome; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Reperfusion Injury; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Akihiko Inoue

  Hyogo Emergency Medical Center

  PRINCIPAL INVESTIGATOR

• Yasuhiro Kuroda

  Kagawa University

  STUDY CHAIR

• Toru Hifumi

  Kyorin University School of Medicine

  STUDY CHAIR

• Tetsuya Sakamoto

  Teikyo University

  STUDY DIRECTOR

• Naoaki Ichihara

  Osaka University

  STUDY DIRECTOR

Central Study Contacts

Akihiko Inoue

CONTACT

81-87-981-2392; j-neuro@googlegroups.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 15, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 27, 2025

Record last verified: 2024-12

Locations

JP (28)