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RECRUITING
NCT06776549
NA

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

Sponsor: Kagawa University

View on ClinicalTrials.gov

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.

Official title: Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest: A Cluster Randomized Trial (SAVE-J NEUROTHERM Trial)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

468

Start Date

2025-01-06

Completion Date

2028-12-31

Last Updated

2025-06-27

Healthy Volunteers

No

Interventions

PROCEDURE

Temperature control

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.

PROCEDURE

Temperature control

Procedure: Temperature control at 36 °C In the normothermia group receiving ECPR, the temperature of 36ºC will be immediately reached with ECMO using a heat exchanger. After reaching this targeted temperature, the maintenance phase will start, and the target temperature will be maintained at 36ºC. The maintenance phase will end 24 h after reaching this targeted temperature. Then, 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.

Locations (28)

Kurume University Hospital

Kurume, Fukuoka, Japan

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Hyogo Prefectural Kakogawa Medical Center

Kakogawa, Hyōgo, Japan

Hyogo Emergency Medical Center

Kobe, Hyōgo, Japan

Toyooka Public Hospital

Toyooka, Hyōgo, Japan

Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan

Oshima Prefectural Hospital

Amami, Kagoshima-ken, Japan

Ebina General Hospital

Ebina, Kanagawa, Japan

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, Japan

Kyoto Second Red Cross Hospital

Kyoto, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Sendai Medical Center

Sendai, Miyagi, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Tsuyama Chuo Hospital

Tsuyama, Okayama-ken, Japan

Okinawa Prefectural Nanbu Medical Center & Children's Medical Center

Shimajiri-gun, Okinawa, Japan

Osaka Saiseikai Senri Hospital

Suita, Osaka, Japan

Saitama Red Cross Hospital

Saitama, Saitama, Japan

Tottori Prefectural Central Hospital

Tottori-shi, Tottori, Japan

St. Luke's International Hospital

Tokyo, Japan

Institute of Science Tokyo Hospital

Tokyo, Japan

Nippon Medical School Hospital

Tokyo, Japan

Tokyo Metropolitan Bokutoh Hospital

Tokyo, Japan

Keio University Hospital

Tokyo, Japan

Japanese Red Cross Musashino Hospital

Tokyo, Japan

Tokyo Metropolitan Tama Medical Center

Tokyo, Japan

National Hospital Organization Disaster Medical Center

Tokyo, Japan