Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest
NCT ID: NCT06776549
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
468 participants
INTERVENTIONAL
2025-01-06
2028-12-31
Brief Summary
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Detailed Description
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ECPR is a resuscitation technique using extracorporeal membrane oxygenation (ECMO) for refractory cardiac arrest. In ECPR patients, ECMO using a heat exchanger can more rapidly achieve the targeted temperature as compared to other temperature control devices. Early cooling to achieve hypothermia after resuscitation is expected to be more effective for neuroprotection in the injured brain. Thus, the investigators hypothesized that hypothermia would be effective in ECPR patients.
Furthermore, ECMO can stabilize the respiratory and circulatory status. Therefore, hypothermia, which may have side effects such as electrolyte abnormalities and arrhythmias, may be safely performed by ECMO. However, ECMO requires the administration of anticoagulants; therefore, it has the risk of hemorrhagic complications. Among patients receiving ECPR, bleeding is a common complication due to its relatively difficult procedure, considering the fact that emergent cannulation is performed under resuscitation. Additionally, CPR-related complications can also result in bleeding. These complications may be enhanced by hypothermia. Therefore, hypothermia after ECPR could contribute to a favorable outcome, but it could also cause bleeding.
The SAVE-J NEUROTHERM trial is a cluster randomized trial that evaluated and compared the mortality risk, neurological outcomes, and adverse events between out-of-hospital cardiac arrest (OHCA) patients who underwent hypothermia and normothermia after ECPR.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Normothermia
Temperature control at 36 °C
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.
Hypothermia
Temperature control at 33-34 °C
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age of 18-75 years, known or estimated
* An initial cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia or pulseless electrical activity
Exclusion Criteria
* 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)
* Consent not obtained or withdrawn by the participant or surrogate
* Other reasons, physician's decision not to enroll the patient
18 Years
75 Years
ALL
No
Sponsors
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Kagawa University
OTHER
Responsible Party
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Akihiko Inoue
Principal Investigator
Principal Investigators
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Akihiko Inoue
Role: PRINCIPAL_INVESTIGATOR
Hyogo Emergency Medical Center
Yasuhiro Kuroda
Role: STUDY_CHAIR
Kagawa University
Toru Hifumi
Role: STUDY_CHAIR
Kyorin University School of Medicine
Tetsuya Sakamoto
Role: STUDY_DIRECTOR
Teikyo University
Naoaki Ichihara
Role: STUDY_DIRECTOR
Osaka University
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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j-neuro
Identifier Type: -
Identifier Source: org_study_id
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