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
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Combination of death and poor neurological function defined as a Cerebral Performance Category (CPC) score 3 to 5 at 180 days
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Arctic Sun® (Device)
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.
干预措施: Arcticgel™ (Device)
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.
干预措施: Conventional antipyretic treatment (Procedure)
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.
干预措施: Conventional antipyretic treatment (Procedure)
结局指标
主要结局
Combination of death and poor neurological function defined as a Cerebral Performance Category (CPC) score 3 to 5 at 180 days
时间窗: 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.
次要结局
- The CPC score 3 to 5 at day 7 and at day 30(day 7, day 30)
- The highest levels of serum neuron specific enolase(NSE) during the first 5 days(up to day 5)
- Unfavorable Electroencephalography(EEG) patterns(day 0, day 4)
- Assessment of magnetic resonance imaging(MRI) at day 4(day 4)
- Modified Rankin Scale(mRS) score 4 to 6 at day 30 and at Day 180(day 30, day 180)
- All-cause mortality at day 30, at Day 180(up 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)
- Other neurological evaluations(day 180)
- Assessment of follow-up MRI(day 30 & day 180)
研究者
Sang-Beom Jeon
Associate Professor
Asan Medical Center