Targeted Temperature Management After In-Hospital Cardiac Arrest
NCT ID: NCT02578823
Last Updated: 2016-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-01-31
2018-04-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TTM-36
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.
Arctic Sun®
Core temperature is maintained to 36℃ for 3 days by using the skin attached pad(Arcticgel™) and targeted temperature management(Arctic Sun®).
Arcticgel™
Conventional antipyretic treatment
Conventional antipyretic treatment for fever includes using of antipyretics, ice packs, circulating fan, and tepid bathing, etc.
Conventional treatment
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.
Conventional antipyretic treatment
Conventional antipyretic treatment for fever includes using of antipyretics, ice packs, circulating fan, and tepid bathing, etc.
Interventions
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Arctic Sun®
Core temperature is maintained to 36℃ for 3 days by using the skin attached pad(Arcticgel™) and targeted temperature management(Arctic Sun®).
Arcticgel™
Conventional antipyretic treatment
Conventional antipyretic treatment for fever includes using of antipyretics, ice packs, circulating fan, and tepid bathing, etc.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Sang-Beom Jeon
Associate Professor
Principal Investigators
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Sang-Beom Jeon, Dr
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-1071
Identifier Type: -
Identifier Source: org_study_id
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