CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)
- Conditions
- Prognostic FactorsMyocardial InjuryTherapyImage, BodyComplicationsCarbon Monoxide PoisoningNeurologic Deficits
- Interventions
- Diagnostic Test: Cardiac MRIProcedure: Hyperbaric oxygen therapy
- Registration Number
- NCT04490317
- Lead Sponsor
- Wonju Severance Christian Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Acute CO poisoning
- Declined to enrollment in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acute CO poisoning Cardiac MRI A diagnosis of CO poisoning is made according to medical history and carboxyhemoglobin \>5% (\>10% in smokers). Acute CO poisoning Hyperbaric oxygen therapy A diagnosis of CO poisoning is made according to medical history and carboxyhemoglobin \>5% (\>10% in smokers).
- Primary Outcome Measures
Name Time Method 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 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method Therapeutic response to TH combined with HBO at 1 month At 1 month after CO exposure Therapeutic response to TH combined with HBO in acute severe CO poisoning at 1 month after CO exposure
Therapeutic response to HBO according to presence of apolipoprotein E4 at 6 months At 6 months after CO exposure Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 6 months 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 HBO according to presence of apolipoprotein E4 genotype 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 in acute severe CO poisoning 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 TH combined with HBO in acute severe CO poisoning 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 Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 1 month after CO exposure
Brain injury evaluated by brain imaging modality related to CO poisoning Within 6 months after CO exposure Brain injury evaluated by brain MRI in CO poisoning
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 Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure
Cardiac injury evaluated by cardiac MRI in acute phase Within 1 month after CO exposure Cardiac injury related to CO poisoning evaluated by cardiac MRI in acute phase
Cardiac injury evaluated by cardiac CT Within 1 month after CO exposure Cardiac injury evaluated by cardiac CT in CO poisoning
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 Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure
Therapeutic response to drugs at 12 months At 12 months after CO exposure Therapeutic response to additional drug including steroid 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 Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 12 months after CO exposure
Complications related to CO poisoning Within 6 months after CO exposure Complications, such as pulmonary thromboembolism or rhabdomyolysis, etc, related to CO poisoning
Therapeutic response to HBO at 12 months At 12 months after CO exposure Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO 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 related to CO poisoning evaluated by cardiac MRI in chronic phase
Cardiac injury evaluated by TTE in acute phase Within 14 days after CO exposure Cardiac injury related to CO poisoning evaluated by TTE in acute phase
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 cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae 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 Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as GDS or CONSB, etc
Therapeutic response to drugs at 1 month At 1 month after CO exposure Therapeutic response to additional drug including steroid 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 Effect of HBO for patient with delayed neurocognitive and psychological sequelae at 1 year after sequelae onset
Cardiac injury evaluated by TTE in chronic phase Within 4-8 months after CO exposure Cardiac injury related to CO poisoning evaluated by TTE in chronic phase
Brain injury related to CO poisoning Within 6 months after CO exposure Brain injury evaluated by laboratory tests in CO poisoning
Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 1 month At 1 month after CO exposure Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 1 month after CO exposure
Organ injury related to CO poisoning Within 6 months after CO exposure Organ injury, such as lung, kidney, liver, pancreas, or bowel, etc, related to CO poisoning
Validation of methods evaluating neurocognitive and psychological outcomes Within 6 months after CO exposure Validation of methods evaluating neurocognitive and psychological outcomes within 6 months
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 cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae 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 MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as GDS or CONSB, etc
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 brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as GDS or CONSB, etc
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, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as GDS or CONSB, etc
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 laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as GDS or CONSB, etc
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 brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by such as GDS or CONSB, etc
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, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as GDS or CONSB, etc
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 Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by such as GDS or CONSB, etc
Therapeutic response to drugs at 6 months At 6 months after CO exposure Therapeutic response to additional drug including steroid 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 evaluated by, such as GDS or CONSB, etc, after CO poisoning 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 Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning 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 Effect of HBO for patient with delayed neurocognitive and psychological sequelae at 2 years after sequelae onset
Trial Locations
- Locations (1)
Wonju Severance Christian Hospital
🇰🇷Wonju, Gangwon, Korea, Republic of