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

NARecruitingINTERVENTIONAL
Enrollment

468

Participants

Timeline

Start Date

January 6, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Out-of-hospital Cardiac Arrest (OHCA)ECMO TreatmentTemperaturePost Cardiac Arrest Syndrome
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.

Trial Locations (28)

1048560

RECRUITING

St. Luke's International Hospital, Tokyo

1138519

RECRUITING

Institute of Science Tokyo Hospital, Tokyo

1138603

RECRUITING

Nippon Medical School Hospital, Tokyo

1308575

RECRUITING

Tokyo Metropolitan Bokutoh Hospital, Tokyo

1608582

RECRUITING

Keio University Hospital, Tokyo

1808610

RECRUITING

Japanese Red Cross Musashino Hospital, Tokyo

1838524

RECRUITING

Tokyo Metropolitan Tama Medical Center, Tokyo

1900014

RECRUITING

National Hospital Organization Disaster Medical Center, Tokyo

2308765

RECRUITING

Saiseikai Yokohamashi Tobu Hospital, Yokohama

2430432

RECRUITING

Ebina General Hospital, Ebina

3308553

RECRUITING

Saitama Red Cross Hospital, Saitama

5650862

RECRUITING

Osaka Saiseikai Senri Hospital, Suita

6028026

NOT_YET_RECRUITING

Kyoto Second Red Cross Hospital, Kyoto

6510073

RECRUITING

Hyogo Emergency Medical Center, Kobe

6688501

RECRUITING

Toyooka Public Hospital, Toyooka

6758555

RECRUITING

Hyogo Prefectural Kakogawa Medical Center, Kakogawa

6800901

RECRUITING

Tottori Prefectural Central Hospital, Tottori-shi

7008558

RECRUITING

Okayama University Hospital, Okayama

7080841

RECRUITING

Tsuyama Chuo Hospital, Tsuyama

7610793

RECRUITING

Kagawa University Hospital, Kita-gun

8300011

RECRUITING

Kurume University Hospital, Kurume

8940015

RECRUITING

Oshima Prefectural Hospital, Amami

9011193

RECRUITING

Okinawa Prefectural Nanbu Medical Center & Children's Medical Center, Shimajiri-gun

9808574

RECRUITING

Tohoku University Hospital, Sendai

9838520

RECRUITING

Sendai Medical Center, Sendai

0788510

NOT_YET_RECRUITING

Asahikawa Medical University Hospital, Asahikawa

0608556

RECRUITING

Sapporo Medical University Hospital, Sapporo

0608648

RECRUITING

Hokkaido University Hospital, Sapporo

All Listed Sponsors
lead

Kagawa University

OTHER