Hypoxic Ischemic EncephalopathyTTM36-IHCANCT02578823
Targeted Temperature Management After In-Hospital Cardiac Arrest
A study testing Arctic Sun®, Arcticgel™ and Conventional antipyretic treatment in people with Hypoxic Ischemic Encephalopathy, run by Asan Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy
- What is being tested?
- Arctic Sun®, Arcticgel™ and Conventional antipyretic treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Sang-Beom Jeon, Dr, 82-2-3010-3440, sbjeonmd@gmail.com
About this study
Official title: 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).
- Conditions
- Hypoxic Ischemic Encephalopathy
- Being tested
- Arctic Sun®, Arcticgel™, Conventional antipyretic treatment
- Keywords
- Targeted Temperature Management(TTM), in-hospital cardiac arrest(IHCA), restoration of spontaneous circulation(ROSC), unconsciousness, brain injury
- Medical subject headings
- Hypoxia-Ischemia, Brain, Unconsciousness, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arctic Sun®Device
Also called Temperature Management System Model 5000
Core temperature is maintained to 36℃ for 3 days by using the skin attached pad(Arcticgel™) and targeted temperature management(Arctic Sun®).
Arcticgel™Device
Also called Hydrogel Coated Pad
Conventional antipyretic treatmentProcedure or surgery
Conventional antipyretic treatment for fever includes using of antipyretics, ice packs, circulating fan, and tepid bathing, etc.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Arctic Sun®; Device: Arcticgel™; Procedure: Conventional antipyretic treatment |
| 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. Receives: Procedure: Conventional antipyretic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 180
Secondary outcomes (10)
The CPC score 3 to 5 at day 7 and at day 30
Measured: day 7, day 30
The highest levels of serum neuron specific enolase(NSE) during the first 5 days
Measured: up to day 5
Unfavorable Electroencephalography(EEG) patterns
- Generalized suppression(≤20 μV)
- Burst-suppression with generalized epileptiform activity
- Generalized periodic epileptiform discharges on a flat background
- No EEG reactivity
- Electrographical seizures
- Electrographical status epilepticus
Measured: day 0, day 4
Assessment of magnetic resonance imaging(MRI) at day 4
- Total magnetic resonance imaging(MRI) scores
- The percentage of brain volume with Afferent Diffusion Coefficient(ADC) values < 650 x 10^-6mm^2/sec
- The percentage of brain volume with ADC values < 450 x 10^-6mm^2/sec
- Number of cerebral microbleeds
Measured: day 4
Modified Rankin Scale(mRS) score 4 to 6 at day 30 and at Day 180
Measured: day 30, day 180
All-cause mortality at day 30, at Day 180
Measured: up to day 180
Myoclonic or tonic-clonic seizures or status epilepticus(SE)
Measured: up to day 7
Neurological status estimated by the Seoul Neurosychological Screeninig Battery (SNSB) 2nd ed.
- Attention: Digit span (forward), digit span (backward)
- Language \& related function: Spontaneous speech, comprehension, repetition, reading, writing, finger naming, body part identification, right-left orientation, calculation; BNT (Boston Naming Test)
- Visuospatial: RCFT (Rey Complex Figure Test) copy score
- Memory: SVLT (Seoul Verbal Learning Test), RCFT (immediate recall, delayed recall, recognition)
- Frontal \& executive function: COWAT (Controlled Oral Word Association Test), CWST (Color Word Stroop Test), DSC (Digit Symbol Coding), TMT (Trail making test)
- General cognitive index: MMSE (Mini Mental State Examination), CDR (Clinical Dementia Rating), GDS (Global Deterioration Scale)
- Activities of daily living (ADL): Barthel index
Measured: day 180
Other neurological evaluations
- Depression: BDI (Beck Depression Inventory)
- Quality of life: SF-36 (Short-Form 36-item Health Survey)
- Activities of daily life: S-IADL (Seoul-Instrumental Activities of Daily Living)
- Psychiatric symptoms: NPI (Neuropsychiatric Inventory)
- Cognition: IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)
- Parkinsonism: UPDRS (Unified Parkinson's Disease Rating Scale)
- Ataxia: ICARS (International Cooperative Ataxia Rating Scale)
Measured: day 180
Assessment of follow-up MRI
- Resting state functional MRI: Connectivity strength, proportional increase of connectivity strength on resting state
- Diffusion tensor imaging: Global mean diffusivity, gray matter mean diffusivity, white matter mean diffusivity , mean fractional anisotropy, proportional increase of white matter global fractional anisotropy, proportional increase of white matter global mean diffusivity
- High resolution T1-weighted imaging for MRI volumetric: Mean volume of the brain, mean volume of the gray matter of the brain, mean volume of the white matter of the brain, proportional increase of mean volume of the brain, proportional increase of mean volume of the gray matter, proportional increase of mean volume of the white matter
- Susceptibility-weighted imaging: Number of cerebral microbleeds
Measured: day 30 & day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Beom Jeon, Asan Medical Center
- Investigators
- Sang-Beom Jeon, Dr, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578823
- Sponsor's protocol ID
- 2015-1071
- Acronym
- TTM36-IHCA
- Status last verified
- Jun 2016
- First submitted
- 15 Oct 2015
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02578823
- Acronym / sponsor ID
- TTM36-IHCA / 2015-1071
- Conditions
- Hypoxic Ischemic Encephalopathy
- Keywords
- Targeted Temperature Management(TTM), in-hospital cardiac arrest(IHCA), restoration of spontaneous circulation(ROSC), unconsciousness, brain injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TTM-36 | Experimental | Device: Arctic Sun®, Device: Arcticgel™, Procedure: Conventional antipyretic treatmentParticipants 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 | Procedure: Conventional antipyretic treatmentParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arctic Sun®Also: Temperature Management System Model 5000Core temperature is maintained to 36℃ for 3 days by using the skin attached pad(Arcticgel™) and targeted temperature management(Arctic Sun®). | Device | TTM-36 |
| Arcticgel™Also: Hydrogel Coated Pad | Device | TTM-36 |
| Conventional antipyretic treatmentConventional antipyretic treatment for fever includes using of antipyretics, ice packs, circulating fan, and tepid bathing, etc. | Procedure or surgery | Conventional treatment, TTM-36 |
Primary outcome
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.
10 secondary outcomes
The CPC score 3 to 5 at day 7 and at day 30
Time frame: day 7, day 30
The highest levels of serum neuron specific enolase(NSE) during the first 5 days
Time frame: up to day 5
Unfavorable Electroencephalography(EEG) patterns
Time frame: day 0, day 4
Assessment of magnetic resonance imaging(MRI) at day 4
Time frame: day 4
Modified Rankin Scale(mRS) score 4 to 6 at day 30 and at Day 180
Time frame: day 30, day 180
All-cause mortality at day 30, at Day 180
Time frame: up to day 180
Myoclonic or tonic-clonic seizures or status epilepticus(SE)
Time frame: up to day 7
Neurological status estimated by the Seoul Neurosychological Screeninig Battery (SNSB) 2nd ed.
Time frame: day 180
Other neurological evaluations
Time frame: day 180
Assessment of follow-up MRI
Time frame: day 30 & day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Beom Jeon, Dr principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arctic Sun®, Arcticgel™ and Conventional antipyretic treatment in people with Hypoxic Ischemic Encephalopathy, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-Beom Jeon, Dr (82-2-3010-3440, sbjeonmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.