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

Not Applicable

Recruiting

• Conditions: Post-cardiac arrest syndrome; Brain injury; coma; heart arrest; complications; D000080942

• Registration Number: JPRN-jRCT1062220035
• Lead Sponsor: aito Hiromichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 380

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eurological outcomes (Favorable outcomes defined as Cerebral Performance Category 1 or 2) [Time Frame: 30 days after cardiac arrest]

Secondary Outcome Measures

Name	Time	Method
eurological outcomes (Favorable outcomes defined as Cerebral Performance Category 1 or 2)[Time Frame: 90 days after cardiac arrest]<br>Mortality (all cause) [Time Frame: 30 days]<br>Mortality (all cause) [Time Frame: 90 days]