Comparing hypothermia and normal temperature after cardiac arrest treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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* Consent not obtained or withdrawn by the participant or surrogate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 it's running

• Kurume University Hospital
  Kurume, Fukuoka, Japan 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

Study contacts

• Principal investigator: Akihiko Inoue — Hyogo Emergency Medical Center
• Study coordinator: Akihiko Inoue
• Email: j-neuro@googlegroups.com
• Phone: 81-87-981-2392

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.