Clinical trial NCT02578823: Targeted Temperature Management After In-Hospital Cardiac Arrest
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxic Ischemic Encephalopathy
Keywords: Targeted Temperature Management(TTM)
in-hospital cardiac arrest(IHCA)
restoration of spontaneous circulation(ROSC)
unconsciousness
brain injury
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Combination of death and poor neurological function defined as a Cerebral Performance Category (CPC) score 3 to 5 at 180 days
timeFrame: day 180
Secondary outcomes:
measure: The CPC score 3 to 5 at day 7 and at day 30
timeFrame: day 7, day 30
measure: The highest levels of serum neuron specific enolase(NSE) during the first 5 days
timeFrame: up to day 5
measure: Unfavorable Electroencephalography(EEG) patterns
timeFrame: day 0, day 4
measure: Assessment of magnetic resonance imaging(MRI) at day 4
timeFrame: day 4
measure: Modified Rankin Scale(mRS) score 4 to 6 at day 30 and at Day 180
timeFrame: day 30, day 180
measure: All-cause mortality at day 30, at Day 180
timeFrame: up to day 180
measure: Myoclonic or tonic-clonic seizures or status epilepticus(SE)
timeFrame: up to day 7
measure: Neurological status estimated by the Seoul Neurosychological Screeninig Battery (SNSB) 2nd ed.
timeFrame: day 180
measure: Other neurological evaluations
timeFrame: day 180
measure: Assessment of follow-up MRI
timeFrame: day 30 & day 180
Other outcomes:
measure: Safety of the targeted temperature management at 36.0℃(TTM-36)
timeFrame: up to day 7
measure: Feasibility
timeFrame: up to day 180
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sang-Beom Jeon, Dr
role: PRINCIPAL_INVESTIGATOR
References: