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Recruiting NCT06776549

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

No phase Interventional Out-of-hospital Cardiac Arrest (OHCA) ECMO Treatment Temperature Post Cardiac Arrest Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Temperature control, Temperature control.
Who it may be relevant to
Registry conditions: Out-of-hospital Cardiac Arrest (OHCA), ECMO Treatment, Temperature, Post Cardiac Arrest Syndrome. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

Temperature control is a key neurointensive care for post-cardiac arrest patients. Although therapeutic hypothermia has been shown to be effective in the past, recent large randomized controlled trials have failed to demonstrate its efficacy. The international guidelines recommend temperature control under 37.7°C. However, the optimal temperature control, i.e., hypothermia versus normothermia, remains controversial. Additionally, randomized controlled trials that examined temperature control after extracorporeal cardiopulmonary resuscitation (ECPR) are lacking.

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.

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 rang
  • 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 3

Primary outcome measures

  • Survival [Time frame: At discharge (approximately 25 days)]
Secondary outcome measures (3)
  • Survival [Time frame: At 30 days, 90 days, and 1 year after admission]
  • Neurological function: Cerebral performance categories (CPC) [Time frame: At discharge (approximately 25 days), 30 days, 90 days, and 1 year after admission]
  • Adverse events [Time frame: During the intensive care unit stay, an average of 2 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Japan · 29 centers
  • Kurume University Hospital — Kurume
  • Asahikawa Medical University Hospital — Asahikawa
  • Sapporo Medical University Hospital — Sapporo
  • Hokkaido University Hospital — Sapporo
  • Hyogo Prefectural Kakogawa Medical Center — Kakogawa
  • Hyogo Emergency Medical Center — Kobe
  • Toyooka Public Hospital — Toyooka
  • Hitachi General Hospital — Hitachi-shi
  • … and 21 more centers

Identifiers

NCT: NCT06776549 · j-neuro

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗