Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients - A Multicenter, Randomized, Adaptive Clinical Trial to Identify the Optimal Duration of Induced Hypothermia for Neuroprotection in Comatose Survivors of Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,158
- 试验地点
- 152
- 主要终点
- Weighted Modified Rankin Scale (mRS)
研究概览
简要总结
A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest.
详细描述
A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest.
Cardiac arrest is a common and devastating emergency of the heart and the brain. More than 380,000 patients suffer out of hospital cardiac arrest (OHCA) each year in the US. Improvements in cardiac resuscitation (the early links in the "chain of survival" for patients with OHCA) are tempered by our limited ability to resuscitate and protect the brain from global cerebral ischemia.
Neurological death and disability are common outcomes in survivors of cardiac arrest. Therapeutic cooling of comatose patients resuscitated from shockable rhythms markedly increases the rate of good neurological outcome, but poor outcomes still occur in as many as 50%, and the benefit of cooling in those resuscitated from asystole and pulseless electrical activity has not been shown in a randomized study.
Objectives:
The overarching goal of this project is to identify clinical strategies that will increase the number of patients with good neurological recovery from cardiac arrest. We hypothesize that longer durations of cooling may improve either the proportion of patients that attain a good neurological recovery or may result in better recovery among the proportion already categorized as having good outcomes.
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)
盲法说明
The outcomes assessors will be blinded to the treatment assignment of the participant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coma after resuscitation from out of hospital cardiac arrest
- •Cooled to <34 deg C with 240 minutes of cardiac arrest
- •Definitive temperature control applied
- •Age ≥ 18 years
- •Informed consent from legal authorized representative (LAR) including intent to maintain life support for 96 hours
- •Enrollment within 6 hours of initiation of cooling
排除标准
- •Hemodynamic instability
- •Pre-existing neurological disability or condition that confounds outcome determination
- •Pre-existing terminal illness, unlikely to survive to outcome determination
- •Planned early withdrawal of life support
- •Presumed sepsis as etiology of arrest
研究组 & 干预措施
24 hours - shockable
Participants with shockable initial rhythm will be assigned to receive 24 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
18 hours - shockable
Participants with shockable initial rhythm will be assigned to receive 18 hours of hypothermia with a target of 33 degrees followed by 18 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
30 hours - shockable
Participants with shockable initial rhythm will be assigned to receive 30 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
36 hours - shockable
Participants with shockable initial rhythm will be assigned to receive 36 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
42 Hours - shockable
Participants with shockable initial rhythm will be assigned to receive 42 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
48 hours - shockable
Participants with shockable initial rhythm will be assigned to receive 48 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
60 hours - shockable
Participants with shockable initial rhythm will be assigned to receive 60 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
72 hours - shockable
Participants with shockable initial rhythm will be assigned to receive 72 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
6 hours - non shockable
Participants with non-shockable initial rhythm will be assigned to receive 6 hours of hypothermia with a target of 33 degrees followed by 6 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
12 hours - non-shockable
Participants with non-shockable initial rhythm will be assigned to receive 12 hours of hypothermia with a target of 33 degrees followed by 12 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
18 hours - non-shockable
Participants with non-shockable initial rhythm will be assigned to receive 18 hours of hypothermia with a target of 33 degrees followed by 18 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
24 hour - non-shockable
Participants with non-shockable initial rhythm will be assigned to receive 24 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
36 hours - non-shockable
Participants with non-shockable initial rhythm will be assigned to receive 36 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
42 hours - non-shockable
Participants with non-shockable initial rhythm will be assigned to receive 42 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
48 hours - non-shockable
Participants with non-shockable initial rhythm will be assigned to receive 48 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
60 hours - non-shockable
Participants with non-shockable initial rhythm will be assigned to receive 60 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
72 hours - non-shockable
Participants with non-shockable initial rhythm will be assigned to receive 72 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
6 hours - shockable
Participants with shockable initial rhythm will be assigned to receive 6 hours of hypothermia with a target of 33 degrees followed by 6 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
12 hours - shockable
Participants with shockable initial rhythm will be assigned to receive 12 hours of hypothermia with a target of 33 degrees followed by 12 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
30 hours - non-shockable
Participants with non-shockable initial rhythm will be assigned to receive 30 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
干预措施: Therapeutic Hypothermia (Device)
结局指标
主要结局
Weighted Modified Rankin Scale (mRS)
时间窗: 90 days after return of spontaneous circulation
The mRS is a 7 level ordinal scale of disability that ranges from 0 (no symptoms at all) to 6 (death). ICECAP uses weighting of mRS states to capture changes in functional status.
次要结局
- All Cause Mortality(90 days after return of spontaneous circulation)
- Pneumonia(90 days after return of spontaneous circulation)
- Electrolyte abnormalities(90 days after return of spontaneous circulation)
- Coagulopathies(90 days after return of spontaneous circulation)
- NIH Toolbox Fluid Cognition Composite Score(90 days after return of spontaneous circulation)
- Other infection(90 days after return of spontaneous circulation)
- Seizures(90 days after return of spontaneous circulation)
- Malignant cardiac arrhythmia(90 days after return of spontaneous circulation)
- Neurological worsening(90 days after return of spontaneous circulation)
- NIH Toolbox Crystallized Cognition Composite Score(90 days after return of spontaneous circulation)
研究者
William J Meurer
Associate Professor of Emergency Medicine and Neurology
University of Michigan