Targeted Temperature Management After In-Hospital Cardiac Arrest
NCT02578823, Not applicable, Unknown, Asan Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Targeted Temperature Management After In-Hospital Cardiac Arrest | ClinicalTrials.gov |
| NCT number | NCT02578823 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Asan Medical Center | ClinicalTrials.gov |
| Conditions | Hypoxic Ischemic Encephalopathy | ClinicalTrials.gov |
| Interventions | Arctic Sun®, Arcticgel™, Conventional antipyretic treatment | ClinicalTrials.gov |
| First posted | 2015-10-19 | ClinicalTrials.gov |
| Last updated | 2016-06-29 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Combination of death and poor neurological function defined as a Cerebral Performance Category (CPC) score 3 to 5 at 180 days | 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. | ClinicalTrials.gov |
| Secondary | The CPC score 3 to 5 at day 7 and at day 30 | day 7, day 30 | ClinicalTrials.gov | |
| Secondary | The highest levels of serum neuron specific enolase(NSE) during the first 5 days | up to day 5 | ClinicalTrials.gov | |
| Secondary | Unfavorable Electroencephalography(EEG) patterns | day 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 | ClinicalTrials.gov |
| Secondary | Assessment of magnetic resonance imaging(MRI) at day 4 | 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 | ClinicalTrials.gov |
| Secondary | Modified Rankin Scale(mRS) score 4 to 6 at day 30 and at Day 180 | day 30, day 180 | ClinicalTrials.gov | |
| Secondary | All-cause mortality at day 30, at Day 180 | up to day 180 | ClinicalTrials.gov | |
| Secondary | Myoclonic or tonic-clonic seizures or status epilepticus(SE) | up to day 7 | ClinicalTrials.gov | |
| Secondary | 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 | ClinicalTrials.gov |
| Secondary | Other neurological evaluations | day 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) | ClinicalTrials.gov |
| Secondary | Assessment of follow-up MRI | day 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 | ClinicalTrials.gov |
| Other | Safety of the targeted temperature management at 36.0℃(TTM-36) | up to day 7 | Safety will be assessed by the composite measurement below everyday during the first 7 days after cardiac arrest. * Cardiac arrest after randomization * Arrhythmia(ventricular fibrillation, ventricular tachycardia, atrial fibrillation, atrial flutter, tachycardia \>130/min lasting more than 1 hour, and bradycardia \<40/min lasting more than 1 hour) * Pneumonia(pulmonary infiltration on the chest radiography and 2 or more of fever, leukocytosis, and purulent tracheobronchial secretions) * Septic shock(sepsis-induced hypotension persisting despite adequate fluid resuscitation) * Culture-proven infection * Major bleeding(bleeding requiring more than 2 units of packed red blood cell over 2 hours, bleeding causing fatality, and symptomatic bleeding in critical organs) * Shivering(the Bedside Shivering Assessment Scale 2-3) | ClinicalTrials.gov |
| Other | Feasibility | up to day 180 | * 2.5 subjects per month can be recruited * At least 50% of all eligible patients can be recruited * No more than 10% of all recruited subjects cross over from one modality to the other * Complete follow-up in at least 90% of all recruited subjects | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 9
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)