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NCT Number: NCT04490317

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

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.

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Key information

Conditions

Carbon Monoxide Poisoning Chemically-Induced Disorders Complications Gas Poisoning Image, Body Myocardial Injury Nervous System Diseases Neurologic Deficits Neurologic Manifestations Pathological Conditions, Signs and Symptoms Poisoning Prognostic Factors Signs and Symptoms Therapy

Sex eligibility

All sexes

Study type

Observational

Primary location

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location status: Recruiting

Location contact

Yong Sung Cha, MD

CONTACT

[email protected]

+82-33-741-1615

Yong Sung Cha, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute CO poisoning

Exclusion criteria

  • Declined to enrollment in the study

Treatment and study plan

Cardiac MRI

Diagnostic Test
  • Cardiac MRI be taken to CO poisoned patients
  • Cardiac CT be taken to CO poisoned patients
  • TTE be taken to CO poisoned patients
  • Brain MRI be taken to CO poisoned patients
  • Neurocognitive function tests be taken to CO poisoned patients
  • Laboratory tests be taken to CO poisoned patients

Other names: Cardiac CT, Transthoracic echocardiography (TTE), Brain MRI, Neurocognitive function tests, Laboratory tests

Hyperbaric Oxygen Therapy

Procedure
  • Hyperbaric oxygen therapy be used for CO poisoned patients
  • Therapeutic hypothermia be used for CO poisoned patients

Other names: Therapeutic hypothermia

Primary outcomes

  1. Therapeutic response to HBO at 1 month

    Time frame: 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

  2. Therapeutic response to HBO at 6 months

    Time frame: 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

  3. 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

    Time frame: 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

  4. 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

    Time frame: 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

  5. 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

    Time frame: 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 outcomes

  1. Therapeutic response to HBO at 12 months

    Time frame: 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

  2. Therapeutic response to TH combined with HBO at 1 month

    Time frame: At 1 month after CO exposure

    Therapeutic response to TH combined with HBO in acute severe CO poisoning at 1 month after CO exposure

  3. Therapeutic response to TH combined with HBO at 6 months

    Time frame: At 6 months after CO exposure

    Therapeutic response to TH combined with HBO in acute severe CO poisoning at 6 months after CO exposure

  4. Therapeutic response to TH combined with HBO at 12 months

    Time frame: At 12 months after CO exposure

    Therapeutic response to TH combined with HBO in acute severe CO poisoning at 12 months after CO exposure

  5. Therapeutic response to HBO according to presence of apolipoprotein E4 at 1 month

    Time frame: At 1 month after CO exposure

    Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 1 month after CO exposure

  6. Therapeutic response to HBO according to presence of apolipoprotein E4 at 6 months

    Time frame: At 6 months after CO exposure

    Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 6 months after CO exposure

  7. Therapeutic response to HBO according to presence of apolipoprotein E4 at 12 months after CO exposure

    Time frame: At 12 months after CO exposure

    Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 12 months after CO exposure

  8. Cardiac injury evaluated by cardiac MRI in acute phase

    Time frame: Within 1 month after CO exposure

    Cardiac injury related to CO poisoning evaluated by cardiac MRI in acute phase

  9. Cardiac injury evaluated by cardiac MRI in chronic phase

    Time frame: Follow-up cardiac MRI (at 4-8 months after CO exposure)

    Cardiac injury related to CO poisoning evaluated by cardiac MRI in chronic phase

  10. Cardiac injury evaluated by cardiac CT

    Time frame: Within 1 month after CO exposure

    Cardiac injury evaluated by cardiac CT in CO poisoning

  11. Cardiac injury evaluated by TTE in acute phase

    Time frame: Within 14 days after CO exposure

    Cardiac injury related to CO poisoning evaluated by TTE in acute phase

  12. Cardiac injury evaluated by TTE in chronic phase

    Time frame: Within 4-8 months after CO exposure

    Cardiac injury related to CO poisoning evaluated by TTE in chronic phase

  13. Brain injury evaluated by brain imaging modality related to CO poisoning

    Time frame: Within 6 months after CO exposure

    Brain injury evaluated by brain MRI in CO poisoning

  14. Brain injury related to CO poisoning

    Time frame: Within 6 months after CO exposure

    Brain injury evaluated by laboratory tests in CO poisoning

  15. 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

    Time frame: 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

  16. 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

    Time frame: 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

  17. 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

    Time frame: 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

  18. 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

    Time frame: 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

  19. 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

    Time frame: 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

  20. 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

    Time frame: 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

  21. 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

    Time frame: 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

  22. 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

    Time frame: 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

  23. 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

    Time frame: 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

  24. 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

    Time frame: 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

  25. 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

    Time frame: 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

  26. 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

    Time frame: 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

  27. Therapeutic response to drugs at 1 month

    Time frame: At 1 month after CO exposure

    Therapeutic response to additional drug including steroid at 1 month after CO exposure

  28. Therapeutic response to drugs at 6 months

    Time frame: At 6 months after CO exposure

    Therapeutic response to additional drug including steroid at 6 months after CO exposure

  29. Therapeutic response to drugs at 12 months

    Time frame: At 12 months after CO exposure

    Therapeutic response to additional drug including steroid at 12 months after CO exposure

  30. Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 1 month

    Time frame: 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

  31. Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 6 months

    Time frame: 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

  32. Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 12 months

    Time frame: 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

  33. Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 5 years

    Time frame: 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

  34. Organ injury related to CO poisoning

    Time frame: Within 6 months after CO exposure

    Organ injury, such as lung, kidney, liver, pancreas, or bowel, etc, related to CO poisoning

  35. Complications related to CO poisoning

    Time frame: Within 6 months after CO exposure

    Complications, such as pulmonary thromboembolism or rhabdomyolysis, etc, related to CO poisoning

  36. Effect of HBO for delayed neurocognitive and psychological dysfunction at 1 year after onset

    Time frame: 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

  37. Effect of HBO for delayed neurocognitive and psychological dysfunction at 2 years after onset

    Time frame: 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

  38. Validation of methods evaluating neurocognitive and psychological outcomes

    Time frame: Within 6 months after CO exposure

    Validation of methods evaluating neurocognitive and psychological outcomes within 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Yong Sung Cha, MD

CONTACT

[email protected]

+82-33-741-1615

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2030
Study completion
2035
First posted
Jul 29, 2020
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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