Targeted Temperature Management After In-Hospital Cardiac Arrest (TTM36-IHCA)

Asan Medical Center

Status: Unknown

Conditions: Hypoxic Ischemic Encephalopathy

Treatments: Device: Arcticgel™; Procedure: Conventional antipyretic treatment; Device: Arctic Sun®

Study type: Interventional

Funder types: Other

Identifiers

NCT02578823

2015-1071

Details and patient eligibility

About

The purpose of this study is to determine whether targeted temperature management at 36.0˚C(TTM-36) in patients who remain unconscious after resuscitation from in-hospital cardiac arrest(IHCA) will reduce death and disability compared with fever control. For this purpose, the current pilot study will be undertaken to establish the feasibility, safety, and surrogate outcomes of hypoxic-ischemic brain injury in 60 patients who remain unconscious after resuscitation from IHCA.

Eligible patients will be randomly assigned in a 2:1 ratio to either TTM-36(n=40) or conventional treatment group(n=20). Randomization will be performed with stratification according to initial rhythm (shockable vs. non-shockable).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-80 years
• In-hospital cardiac arrest requiring chest compression for > 2 minutes
• Sustained restoration of spontaneous circulation(ROSC) for > 20 minutes after cardiopulmonary resuscitation(CPR)
• Unresponsive state(lack of meaningful response to verbal commands) for > 20 minutes after sustained ROSC
• Informed consents from a patient's family member

Exclusion criteria

• Unavailable TTM within 2 hours after ROSC
• CPR duration > 30 minutes
• Unwitnessed arrest with initial rhythm asystole
• Under or planned for extracorporeal membrane oxygenation(ECMO)
• Initial body temperature < 33 °C
• Preexisting terminal illness with life expectancy <6 months
• Pre-admission CPC score of 3-5
• Pre-admission mRS score 4-6
• Unresponsive(stupor or coma) before cardiac arrest
• Suspected or confirmed cause of cardiac arrest is diseases of the central nervous system, such as stroke, brain tumor, or amyotrophic lateral sclerosis
• Any condition in which direct skin surface cooling would be contraindicated, such as large burns, unhealed surgical wounds, decubitus ulcers, cellulitis, or other conditions with disrupted skin integrity
• Active massive bleeding
• Major surgery within last 48 hours
• Cardiothoracic surgery within 14 days
• Planned surgery within next 72 hours after ROSC
• Enrolled in other clinical trials
• Pregnant women
• Do-not-resuscitate(DNR) state
• Patients whose family or treating physicians refuse to join this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

TTM-36

Experimental group

Description:

Participants assigned to TTM-36 Arm will be managed by Arcticgel™ and Arctic Sun® to maintain core temperatureTemperature at 36.0℃ for 72 hours. After targeted temperature management(TTM), Fever will be controlled for remaining 7 days by conventional antipyretic treatment. (Treat core temperature ≥ 38.3℃). A total of 40 participants will be enrolled.

Treatment:

Device: Arctic Sun®

Procedure: Conventional antipyretic treatment

Device: Arcticgel™

Conventional treatment

Active Comparator group

Description:

Participants who are assigned to this Arm will be treated with conventional antipyretic treatment regarding the occurrence fever for 7 days.(Treat core temperature ≥ 38.3℃). A total of 20 participants will be enrolled.

Treatment:

Procedure: Conventional antipyretic treatment