- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02578823
Targeted Temperature Management After In-Hospital Cardiac Arrest (TTM36-IHCA)
Targeted Temperature Management at 36℃ After In-Hospital Cardiac Arrest Trial(TTM36-IHCA Trial): An Investigator-Initiated, Single-Center, Randomized, Controlled, Assessor-Blinded, Pilot Clinical Trial
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sang-Beom Jeon, Dr
- Phone Number: 82-2-3010-3440
- Email: sbjeonmd@gmail.com
Study Locations
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-
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Seoul, Korea, Republic of, 05505
- Recruiting
- Asan Medical Center
-
Contact:
- Sang-Beom Jeon, Dr
- Phone Number: 82-2-3010-3440
- Email: sbjeonmd@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
Core temperature is maintained to 36℃ for 3 days by using the skin attached pad(Arcticgel™) and targeted temperature management(Arctic Sun®).
Other Names:
Other Names:
Conventional antipyretic treatment for fever includes using of antipyretics, ice packs, circulating fan, and tepid bathing, etc.
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Active Comparator: 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 for fever includes using of antipyretics, ice packs, circulating fan, and tepid bathing, etc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: day 180
|
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.
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day 180
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The CPC score 3 to 5 at day 7 and at day 30
Time Frame: day 7, day 30
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day 7, day 30
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The highest levels of serum neuron specific enolase(NSE) during the first 5 days
Time Frame: up to day 5
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up to day 5
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Unfavorable Electroencephalography(EEG) patterns
Time Frame: day 0, day 4
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day 0, day 4
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Assessment of magnetic resonance imaging(MRI) at day 4
Time Frame: day 4
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day 4
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Modified Rankin Scale(mRS) score 4 to 6 at day 30 and at Day 180
Time Frame: day 30, day 180
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day 30, day 180
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All-cause mortality at day 30, at Day 180
Time Frame: up to day 180
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up to day 180
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Myoclonic or tonic-clonic seizures or status epilepticus(SE)
Time Frame: up to day 7
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up to day 7
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Neurological status estimated by the Seoul Neurosychological Screeninig Battery (SNSB) 2nd ed.
Time Frame: day 180
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day 180
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Other neurological evaluations
Time Frame: day 180
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day 180
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Assessment of follow-up MRI
Time Frame: day 30 & day 180
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day 30 & day 180
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of the targeted temperature management at 36.0℃(TTM-36)
Time Frame: up to day 7
|
Safety will be assessed by the composite measurement below everyday during the first 7 days after cardiac arrest.
|
up to day 7
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Feasibility
Time Frame: up to day 180
|
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up to day 180
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sang-Beom Jeon, Dr, Asan Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Central Nervous System Diseases
- Nervous System Diseases
- Signs and Symptoms, Respiratory
- Hypoxia
- Hypoxia, Brain
- Brain Ischemia
- Brain Diseases
- Heart Arrest
- Hypoxia-Ischemia, Brain
- Physiological Effects of Drugs
- Antipyretics
Other Study ID Numbers
- 2015-1071
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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