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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TTM-36 | Experimental | 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. |
|
| Conventional treatment | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arctic Sun® | Device | Core temperature is maintained to 36℃ for 3 days by using the skin attached pad(Arcticgel™) and targeted temperature management(Arctic Sun®). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combination of death and poor neurological function defined as a Cerebral Performance Category (CPC) score 3 to 5 at 180 days | Efficacy of targeted temperature management at 36.0℃(TTM-36) will be assessed by using Cerebral Performance Category(CPC) score. CPC score is the surrogate outcome for hypoxic-ischemic brain injury. | day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| The CPC score 3 to 5 at day 7 and at day 30 | day 7, day 30 | |
| The highest levels of serum neuron specific enolase(NSE) during the first 5 days | up to day 5 | |
| Unfavorable Electroencephalography(EEG) patterns |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the targeted temperature management at 36.0℃(TTM-36) | Safety will be assessed by the composite measurement below everyday during the first 7 days after cardiac arrest.
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang-Beom Jeon, Dr | Contact | 82-2-3010-3440 | sbjeonmd@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sang-Beom Jeon, Dr | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| D014474 | Unconsciousness |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Arcticgel™ | Device |
|
|
| Conventional antipyretic treatment | Procedure | Conventional antipyretic treatment for fever includes using of antipyretics, ice packs, circulating fan, and tepid bathing, etc. |
|
|
| day 0, day 4 |
| Assessment of magnetic resonance imaging(MRI) at day 4 |
| day 4 |
| Modified Rankin Scale(mRS) score 4 to 6 at day 30 and at Day 180 | day 30, day 180 |
| All-cause mortality at day 30, at Day 180 | up to day 180 |
| Myoclonic or tonic-clonic seizures or status epilepticus(SE) | up to day 7 |
| Neurological status estimated by the Seoul Neurosychological Screeninig Battery (SNSB) 2nd ed. |
| day 180 |
| Other neurological evaluations |
| day 180 |
| Assessment of follow-up MRI |
| day 30 & day 180 |
| up to day 7 |
| Feasibility |
| up to day 180 |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |