CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as neurocognitive function tests
研究概览
简要总结
This prospective cohort study enrolls subjects who experience carbon monoxide (CO) poisoning. The purpose of the study is to evaluate therapeutic effects of various treatments and short and long-term outcomes in CO poisoned patients. In addition, complications of brain and heart susceptible to CO are investigated through various ways and the association between complications and the patient's prognosis is also investigated. All subjects will be regularly monitored by physicians participating in this study.
详细描述
This prospective cohort study enrolls subjects who experience CO poisoning. The purpose of the study is to evaluate therapeutic effects of various treatments, including hyperbaric oxygen therapy (HBO), therapeutic hypothermia (TH), and additional drugs, and short and long-term outcomes, such as neurocognitive sequelae or mortality, in CO poisoned patients. In addition, complications of brain and heart susceptible to CO are investigated through a variety of ways, such as magnetic resonance image (MRI), computed tomography (CT), ultrasound, and laboratory test, and the association between various complications and the patient's prognosis is also investigated. All subjects will be regularly monitored by physicians participating in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute CO poisoning
排除标准
- •Declined to enrollment in the study
结局指标
主要结局
Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as neurocognitive function tests
时间窗: Within 1 month after CO exposure
Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month
Therapeutic response to HBO at 1 month
时间窗: At 1 month after CO exposure
Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 1 month after CO exposure
Therapeutic response to HBO at 6 months
时间窗: At 6 months after CO exposure
Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 6 months after CO exposure
Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as neurocognitive function tests
时间窗: Within 1 month after CO exposure
Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month
Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as neurocognitive function tests
时间窗: Within 1 month after CO exposure
Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month
次要结局
- Therapeutic response to HBO according to presence of apolipoprotein E4 at 6 months(At 6 months after CO exposure)
- Therapeutic response to TH combined with HBO at 1 month(At 1 month after CO exposure)
- Therapeutic response to HBO according to presence of apolipoprotein E4 at 12 months after CO exposure(At 12 months after CO exposure)
- Therapeutic response to TH combined with HBO at 6 months(At 6 months after CO exposure)
- Therapeutic response to TH combined with HBO at 12 months(At 12 months after CO exposure)
- Therapeutic response to HBO according to presence of apolipoprotein E4 at 1 month(At 1 month after CO exposure)
- Brain injury evaluated by brain imaging modality related to CO poisoning(Within 6 months after CO exposure)
- Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure(Outcomes at 12 months after CO exposure)
- Cardiac injury evaluated by cardiac MRI in acute phase(Within 1 month after CO exposure)
- Cardiac injury evaluated by cardiac CT(Within 1 month after CO exposure)
- Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure(Outcomes at 5 years after CO exposure)
- Therapeutic response to drugs at 12 months(At 12 months after CO exposure)
- Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 12 months(At 12 months after CO exposure)
- Complications related to CO poisoning(Within 6 months after CO exposure)
- Therapeutic response to HBO at 12 months(At 12 months after CO exposure)
- Cardiac injury evaluated by cardiac MRI in chronic phase(Follow-up cardiac MRI (at 4-8 months after CO exposure))
- Cardiac injury evaluated by TTE in acute phase(Within 14 days after CO exposure)
- Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure(Outcomes at 1 month after CO exposure)
- Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by neurocognitive function tests(Outcomes at 12 months after CO exposure)
- Therapeutic response to drugs at 1 month(At 1 month after CO exposure)
- Effect of HBO for delayed neurocognitive and psychological dysfunction at 1 year after onset(Within 1 year after delayed neurocognitive and psychological sequelae onset)
- Cardiac injury evaluated by TTE in chronic phase(Within 4-8 months after CO exposure)
- Brain injury related to CO poisoning(Within 6 months after CO exposure)
- Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 1 month(At 1 month after CO exposure)
- Organ injury related to CO poisoning(Within 6 months after CO exposure)
- Validation of methods evaluating neurocognitive and psychological outcomes(Within 6 months after CO exposure)
- Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure(Outcomes at 6 months after CO exposure)
- Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by neurocognitive function tests(Outcomes at 1 month after CO exposure)
- Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by neurocognitive function tests(Outcomes at 6 months after CO exposure)
- Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by neurocognitive function tests(Outcomes at 6 months after CO exposure)
- Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by neurocognitive function tests(Outcomes at 12 months after CO exposure)
- Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by neurocognitive function tests(Outcomes at 5 years after CO exposure)
- Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by neurocognitive function tests(Outcomes at 1 month after CO exposure)
- Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by neurocognitive function tests(Outcomes at 5 years after CO exposure)
- Therapeutic response to drugs at 6 months(At 6 months after CO exposure)
- Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 6 months(At 6 months after CO exposure)
- Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 5 years(At 5 years after CO exposure)
- Effect of HBO for delayed neurocognitive and psychological dysfunction at 2 years after onset(Within 2 years after delayed neurocognitive and psychological sequelae onset)
研究者
Yong Sung Cha
Assistant Professor
Wonju Severance Christian Hospital