Comparing hypothermia and normal temperature after cardiac arrest treatment

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

This study is testing whether cooling the body or keeping it at normal temperature after cardiac arrest helps patients recover better and live longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 468 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kagawa University (Academic / other)
• Locations: 28 sites (Kurume, Fukuoka and 27 other locations)
• Trial ID: NCT06776549 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effects of hypothermia versus normothermia on mortality and neurological outcomes in patients who have undergone extracorporeal cardiopulmonary resuscitation (ECPR) following out-of-hospital cardiac arrest. It aims to determine the optimal temperature control strategy for neuroprotection in these patients, as previous studies have shown mixed results regarding the efficacy of therapeutic hypothermia. The study involves a cluster randomized design and focuses on patients aged 18-75 with specific cardiac arrest rhythms. The research is conducted at multiple hospitals in Japan, utilizing ECMO technology to facilitate rapid temperature control.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who have experienced out-of-hospital cardiac arrest with specific initial cardiac rhythms.

Not a fit: Patients who have a non-cardiac cause for their cardiac arrest or those who have sustained return of spontaneous circulation before ECMO initiation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve survival rates and neurological outcomes for patients who experience out-of-hospital cardiac arrest.

How similar studies have performed: While previous studies on therapeutic hypothermia have shown mixed results, this specific approach using ECPR and temperature control is relatively novel.

Eligibility criteria

Inclusion Criteria:

* OHCA
* 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:

* ECMO initiated after sustained return of spontaneous circulation (ROSC) and patients with sustained ROSC before ECMO initiation
* 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

Where this trial is running

Kurume, Fukuoka and 27 other locations

• Kurume University Hospital — Kurume, Fukuoka, Japan (Recruiting)
• Asahikawa Medical University Hospital — Asahikawa, Hokkaido, Japan (Not_yet_recruiting)
• Sapporo Medical University Hospital — Sapporo, Hokkaido, Japan (Recruiting)
• Hokkaido University Hospital — Sapporo, Hokkaido, Japan (Recruiting)
• Hyogo Prefectural Kakogawa Medical Center — Kakogawa, Hyōgo, Japan (Recruiting)
• Hyogo Emergency Medical Center — Kobe, Hyōgo, Japan (Recruiting)
• Toyooka Public Hospital — Toyooka, Hyōgo, Japan (Recruiting)
• Kagawa University Hospital — Kita-gun, Kagawa-ken, Japan (Recruiting)
• Oshima Prefectural Hospital — Amami, Kagoshima-ken, Japan (Recruiting)
• Ebina General Hospital — Ebina, Kanagawa, Japan (Recruiting)
• Saiseikai Yokohamashi Tobu Hospital — Yokohama, Kanagawa, Japan (Recruiting)
• Kyoto Second Red Cross Hospital — Kyoto, Kyoto, Japan (Not_yet_recruiting)
• Tohoku University Hospital — Sendai, Miyagi, Japan (Recruiting)
• Sendai Medical Center — Sendai, Miyagi, Japan (Recruiting)
• Okayama University Hospital — Okayama, Okayama-ken, Japan (Recruiting)
• Tsuyama Chuo Hospital — Tsuyama, Okayama-ken, Japan (Recruiting)
• Okinawa Prefectural Nanbu Medical Center & Children's Medical Center — Shimajiri-gun, Okinawa, Japan (Recruiting)
• Osaka Saiseikai Senri Hospital — Suita, Osaka, Japan (Recruiting)
• Saitama Red Cross Hospital — Saitama, Saitama, Japan (Recruiting)
• Tottori Prefectural Central Hospital — Tottori-shi, Tottori, Japan (Recruiting)
• St. Luke's International Hospital — Tokyo, Japan (Recruiting)
• Institute of Science Tokyo Hospital — Tokyo, Japan (Recruiting)
• Nippon Medical School Hospital — Tokyo, Japan (Recruiting)
• Tokyo Metropolitan Bokutoh Hospital — Tokyo, Japan (Recruiting)
• Keio University Hospital — Tokyo, Japan (Recruiting)
• Japanese Red Cross Musashino Hospital — Tokyo, Japan (Recruiting)
• Tokyo Metropolitan Tama Medical Center — Tokyo, Japan (Recruiting)
• National Hospital Organization Disaster Medical Center — Tokyo, Japan (Recruiting)

Study contacts

• Principal investigator: Akihiko Inoue — Hyogo Emergency Medical Center
• Study coordinator: Akihiko Inoue

Conditions Out-of-hospital Cardiac Arrest; ECMO Treatment; Temperature; Post Cardiac Arrest Syndrome; Cardiac arrest; Out-of-hospital cardiac arrest; Extracorporeal cardiopulmonary resuscitation; Temperature control