468
Participants
Start Date
January 6, 2025
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2028
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.
RECRUITING
St. Luke's International Hospital, Tokyo
RECRUITING
Institute of Science Tokyo Hospital, Tokyo
RECRUITING
Nippon Medical School Hospital, Tokyo
RECRUITING
Tokyo Metropolitan Bokutoh Hospital, Tokyo
RECRUITING
Keio University Hospital, Tokyo
RECRUITING
Japanese Red Cross Musashino Hospital, Tokyo
RECRUITING
Tokyo Metropolitan Tama Medical Center, Tokyo
RECRUITING
National Hospital Organization Disaster Medical Center, Tokyo
RECRUITING
Saiseikai Yokohamashi Tobu Hospital, Yokohama
RECRUITING
Ebina General Hospital, Ebina
RECRUITING
Saitama Red Cross Hospital, Saitama
RECRUITING
Osaka Saiseikai Senri Hospital, Suita
NOT_YET_RECRUITING
Kyoto Second Red Cross Hospital, Kyoto
RECRUITING
Hyogo Emergency Medical Center, Kobe
RECRUITING
Toyooka Public Hospital, Toyooka
RECRUITING
Hyogo Prefectural Kakogawa Medical Center, Kakogawa
RECRUITING
Tottori Prefectural Central Hospital, Tottori-shi
RECRUITING
Okayama University Hospital, Okayama
RECRUITING
Tsuyama Chuo Hospital, Tsuyama
RECRUITING
Kagawa University Hospital, Kita-gun
RECRUITING
Kurume University Hospital, Kurume
RECRUITING
Oshima Prefectural Hospital, Amami
RECRUITING
Okinawa Prefectural Nanbu Medical Center & Children's Medical Center, Shimajiri-gun
RECRUITING
Tohoku University Hospital, Sendai
RECRUITING
Sendai Medical Center, Sendai
NOT_YET_RECRUITING
Asahikawa Medical University Hospital, Asahikawa
RECRUITING
Sapporo Medical University Hospital, Sapporo
RECRUITING
Hokkaido University Hospital, Sapporo
Kagawa University
OTHER