Randomized Controlled Trial Assessing Temperature Management after Out-of-Hospital Cardiac Arrest with Moderate Initial Illness Severity

Hypothermia versus Normothermia: Comparing 30-day Neurological Outcomes after Out-of-Hospital Cardiac Arrest with Moderate Initial Illness Severity: Multicenter Randomized Controlled Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1062220035

Enrollment

380

Registered

2022-06-16

Start date

2022-07-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-cardiac arrest syndrome Brain injury

Interventions

Patients with out-of-hospital cardiac arrest and ROSC will be randomly assigned to either the hypothermia group or normothermia group. In the hypothermia group, patients will be cooled with a temperat

D007036

Hypothermia, Induced

body temperature

cardiopulmonary resuscitation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Out-of-hospital cardiac arrest with medical pathogenesis (medical pathogenesis includes cases in which the cause of the cardiac arrest is presumed to be cardiac, other medical cause [eg, anaphylaxis, asthma, GI bleed], and in which there is no obvious cause of the cardiac arrest) 2) Age 18 years old or older but not older than 79 years 3) Sustained return of spontaneous circulation (ROSC defined as 20 minutes with signs of circulation without the need for chest compressions), unconscious (defined as Glasgow Coma Scale [GCS] score of 8 or less and GCS motor response score of 5 or less) 4) Eligible for intensive care without any restrictions or specific limitations (No limitations in therapy and does not have a Do-Not-Attempt-Resuscitation order) 5) Randomization within 180 minutes after ROSC 6) Post-cardiac arrest syndrome of moderate severity (defined by revised post-cardiac arrest syndrome for therapeutic hypothermia (rCAST) score: rCAST of 5.5 to 15.5)

Exclusion criteria

Exclusion criteria: 1) Major hemodynamic instability (Systolic blood pressure 80 mmHg or lower despite fluid loading/vasopressors or inotropic support) 2) Temperature on admission 32 degrees Celsius or lower or 40 degrees Celsius or higher 3) Supported by extracorporeal membrane oxygenation prior to ROSC 4) Pregnancy 5) Patients with acute intracranial bleeding, acute subarachnoid hemorrhage, acute cerebral infarction, acute aortic dissection, or end-stage cancer 6) Severe chronic obstructive pulmonary disease (COPD) with home oxygen therapy 7) Chronic kidney disease requiring dialysis 8) Pre-arrest Cerebral Performance Category 3 or 4 or Overall Performance Category 3 or 4 9) Known disease or condition that makes survival with the 40-hour intervention period unlikely

Design outcomes

Primary

Measure	Time frame
Neurological outcomes (Favorable outcomes defined as Cerebral Performance Category 1 or 2) [Time Frame: 30 days after cardiac arrest]	—

Secondary

Measure	Time frame
Neurological outcomes (Favorable outcomes defined as Cerebral Performance Category 1 or 2)[Time Frame: 90 days after cardiac arrest] Mortality (all cause) [Time Frame: 30 days] Mortality (all cause) [Time Frame: 90 days]	—

Contacts

Public ContactHiromichi Naito

Okayama University Faculty of Medicine, Dentistry and Pharmaceutical Sciences

naito-hiromichi@s.okayama-u.ac.jp+81-86-235-7427

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026