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

JRCT ID: jRCT1062220035

Registered date:16/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Post-cardiac arrest syndrome
• Date of first enrollment: 10/07/2022
• Target sample size: 380
• Study type: Interventional

Intervention(s)

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 temperature management device to reach to the target temperature of 34 degrees Celsius. Body temperature will be maintained at 34 degrees Celsius for 28 hours after randomization, followed by rewarming to 37 degrees Celsius with a rewarming speed of 0.25 degrees Celsius/hour.
In the normothermia group, patients will be maintained at normothermia (36.5 degrees Celsius to 37.7 degrees Celsius). Pharmacologic measures or a cooling device will be used to maintain body temperature.
Patients in both groups will be sedated until the end of the intervention period.

Outcome(s)

• Primary Outcome: Neurological outcomes (Favorable outcomes defined as Cerebral Performance Category 1 or 2) [Time Frame: 30 days after cardiac arrest]

Secondary Outcome

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]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 79age old
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Naito Hiromichi
• Source(s) of Monetary Support: Japan Society for the Promotion of Science KAKENHI