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Targeted Temperature Management After In-Hospital Cardiac Arrest

Not Applicable
Conditions
Hypoxic Ischemic Encephalopathy
Interventions
Device: Arctic Sun®
Device: Arcticgel™
Procedure: Conventional antipyretic treatment
Registration Number
NCT02578823
Lead Sponsor
Asan Medical Center
Brief 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. 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).

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
TTM-36Arctic Sun®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.
TTM-36Conventional 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.
TTM-36Arcticgel™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 treatmentConventional 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.
Primary Outcome Measures
NameTimeMethod
Combination of death and poor neurological function defined as a Cerebral Performance Category (CPC) score 3 to 5 at 180 daysday 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.

Secondary Outcome Measures
NameTimeMethod
The CPC score 3 to 5 at day 7 and at day 30day 7, day 30
The highest levels of serum neuron specific enolase(NSE) during the first 5 daysup to day 5
Unfavorable Electroencephalography(EEG) patternsday 0, day 4

* 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

Assessment of magnetic resonance imaging(MRI) at day 4day 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

Modified Rankin Scale(mRS) score 4 to 6 at day 30 and at Day 180day 30, day 180
All-cause mortality at day 30, at Day 180up 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

* 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

Other neurological evaluationsday 180

* 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)

Assessment of follow-up MRIday 30 & day 180

* 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

Trial Locations

Locations (1)

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

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