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Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest
Sponsor: Kagawa University
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
Conditions
Interventions
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.
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