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CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)

CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04490317
Enrollment
1500
Registered
2020-07-29
Start date
2020-07-29
Completion date
2035-12-31
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbon Monoxide Poisoning, Complications, Image, Body, Myocardial Injury, Neurologic Deficits, Prognostic Factors, Therapy

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.

Interventions

DIAGNOSTIC_TESTCardiac MRI

1. Cardiac MRI be taken to CO poisoned patients 2. Cardiac CT be taken to CO poisoned patients 3. TTE be taken to CO poisoned patients 4. Brain MRI be taken to CO poisoned patients 5. Neurocognitive function tests be taken to CO poisoned patients 6. Laboratory tests be taken to CO poisoned patients

PROCEDUREHyperbaric oxygen therapy

1. Hyperbaric oxygen therapy be used for CO poisoned patients 2. Therapeutic hypothermia be used for CO poisoned patients

Sponsors

Wonju Severance Christian Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Acute CO poisoning

Exclusion criteria

* Declined to enrollment in the study

Design outcomes

Primary

MeasureTime frameDescription
Therapeutic response to HBO at 1 monthAt 1 month after CO exposureTherapeutic 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 monthsAt 6 months after CO exposureTherapeutic 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 1 month after CO exposure evaluated by such as neurocognitive function testsWithin 1 month after CO exposurePredictors 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
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 testsWithin 1 month after CO exposurePredictors 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 testsWithin 1 month after CO exposurePredictors 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

MeasureTime frameDescription
Therapeutic response to HBO according to presence of apolipoprotein E4 at 6 monthsAt 6 months after CO exposureTherapeutic 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 exposureAt 12 months after CO exposureTherapeutic response to HBO according to presence of apolipoprotein E4 genotype at 12 months after CO exposure
Cardiac injury evaluated by cardiac MRI in acute phaseWithin 1 month after CO exposureCardiac injury related to CO poisoning evaluated by cardiac MRI in acute phase
Cardiac injury evaluated by cardiac MRI in chronic phaseFollow-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 cardiac CTWithin 1 month after CO exposureCardiac injury evaluated by cardiac CT in CO poisoning
Cardiac injury evaluated by TTE in acute phaseWithin 14 days after CO exposureCardiac injury related to CO poisoning evaluated by TTE in acute phase
Cardiac injury evaluated by TTE in chronic phaseWithin 4-8 months after CO exposureCardiac injury related to CO poisoning evaluated by TTE in chronic phase
Brain injury evaluated by brain imaging modality related to CO poisoningWithin 6 months after CO exposureBrain injury evaluated by brain MRI in CO poisoning
Brain injury related to CO poisoningWithin 6 months after CO exposureBrain injury evaluated by laboratory tests 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 1 month after CO exposureOutcomes at 1 month after CO exposureAssociation 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 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 exposureOutcomes at 6 months after CO exposureAssociation 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 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 exposureOutcomes at 12 months after CO exposureAssociation 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
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 exposureOutcomes at 5 years after CO exposureAssociation 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
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 testsOutcomes at 1 month after CO exposureAssociation 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 testsOutcomes at 6 months after CO exposureAssociation 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 brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by neurocognitive function testsOutcomes at 12 months after CO exposureAssociation 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
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 testsOutcomes at 5 years after CO exposureAssociation 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 testsOutcomes at 1 month after CO exposureAssociation 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 6 months after CO exposure evaluated by neurocognitive function testsOutcomes at 6 months after CO exposureAssociation 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 testsOutcomes at 12 months after CO exposureAssociation 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 laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by neurocognitive function testsOutcomes at 5 years after CO exposureAssociation 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 1 monthAt 1 month after CO exposureTherapeutic response to additional drug including steroid at 1 month after CO exposure
Therapeutic response to drugs at 6 monthsAt 6 months after CO exposureTherapeutic response to additional drug including steroid at 6 months after CO exposure
Therapeutic response to drugs at 12 monthsAt 12 months after CO exposureTherapeutic 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 1 monthAt 1 month after CO exposurePrevalence 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
Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 6 monthsAt 6 months after CO exposurePrevalence 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 12 monthsAt 12 months after CO exposurePrevalence 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
Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 5 yearsAt 5 years after CO exposurePrevalence 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
Organ injury related to CO poisoningWithin 6 months after CO exposureOrgan injury, such as lung, kidney, liver, pancreas, or bowel, etc, related to CO poisoning
Complications related to CO poisoningWithin 6 months after CO exposureComplications, such as pulmonary thromboembolism or rhabdomyolysis, etc, related to CO poisoning
Effect of HBO for delayed neurocognitive and psychological dysfunction at 1 year after onsetWithin 1 year after delayed neurocognitive and psychological sequelae onsetEffect of HBO for patient with delayed neurocognitive and psychological sequelae at 1 year after sequelae onset
Effect of HBO for delayed neurocognitive and psychological dysfunction at 2 years after onsetWithin 2 years after delayed neurocognitive and psychological sequelae onsetEffect of HBO for patient with delayed neurocognitive and psychological sequelae at 2 years after sequelae onset
Therapeutic response to HBO at 12 monthsAt 12 months after CO exposureTherapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 12 months after CO exposure
Validation of methods evaluating neurocognitive and psychological outcomesWithin 6 months after CO exposureValidation of methods evaluating neurocognitive and psychological outcomes within 6 months
Therapeutic response to TH combined with HBO at 1 monthAt 1 month after CO exposureTherapeutic response to TH combined with HBO in acute severe CO poisoning at 1 month after CO exposure
Therapeutic response to TH combined with HBO at 6 monthsAt 6 months after CO exposureTherapeutic 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 monthsAt 12 months after CO exposureTherapeutic 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 monthAt 1 month after CO exposureTherapeutic response to HBO according to presence of apolipoprotein E4 genotype at 1 month after CO exposure

Countries

South Korea

Contacts

Primary ContactYong Sung Cha, MD
emyscha@yonsei.ac.kr+82-33-741-1615

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026