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Carbon Monoxide PoisoningNCT04490317

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

An observational study of Carbon Monoxide Poisoning and Myocardial Injury, run by Wonju Severance Christian Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Cardiac MRI and Hyperbaric oxygen therapy
Type of treatment
Surgery or procedure
How many people
1,500 participants
Where
1 siteSouth Korea
Study dates
29 Jul 2020to Dec 2035
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Acute CO poisoning

Who may be able to join

  • Acute CO poisoning

Who cannot join

  • Declined to enrollment in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yong Sung Cha, MD contact

+82-33-741-1615

emyscha@yonsei.ac.kr

South Korea1 site, 1 recruiting

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

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

    Yong Sung Cha, MD

    Recruiting

Other trials in South Korea

About this study

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.

Read the 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.

Being tested
Cardiac MRI, Hyperbaric oxygen therapy
Medical subject headings
Carbon Monoxide Poisoning, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac MRIDiagnostic test

    Also called Cardiac CT, Transthoracic echocardiography (TTE), Brain MRI, Neurocognitive function tests

    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

  • Hyperbaric oxygen therapyProcedure or surgery

    Also called Therapeutic hypothermia

    1. Hyperbaric oxygen therapy be used for CO poisoned patients
    2. Therapeutic hypothermia be used for CO poisoned patients
Study groups in NCT04490317
Study groupRoleWhat they receive
Acute CO poisoningA diagnosis of CO poisoning is made according to medical history and carboxyhemoglobin >5% (>10% in smokers).
Receives: Diagnostic Test: Cardiac MRI; Procedure: Hyperbaric oxygen therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Therapeutic response to HBO at 1 month

    Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 1 month after CO exposure

    Measured: At 1 month after CO exposure

  2. Therapeutic response to HBO at 6 months

    Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 6 months after CO exposure

    Measured: 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

    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

    Measured: Within 1 month after CO exposure

  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

    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

    Measured: Within 1 month after CO exposure

  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

    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

    Measured: Within 1 month after CO exposure

Secondary outcomes (38)

  1. Therapeutic response to HBO at 12 months

    Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 12 months after CO exposure

    Measured: At 12 months after CO exposure

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

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

    Measured: At 1 month after CO exposure

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

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

    Measured: At 6 months after CO exposure

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

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

    Measured: At 12 months after CO exposure

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

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

    Measured: At 1 month after CO exposure

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

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

    Measured: At 6 months after CO exposure

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

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

    Measured: At 12 months after CO exposure

  8. Cardiac injury evaluated by cardiac MRI in acute phase

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

    Measured: Within 1 month after CO exposure

  9. Cardiac injury evaluated by cardiac MRI in chronic phase

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

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

  10. Cardiac injury evaluated by cardiac CT

    Cardiac injury evaluated by cardiac CT in CO poisoning

    Measured: Within 1 month after CO exposure

  11. Cardiac injury evaluated by TTE in acute phase

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

    Measured: Within 14 days after CO exposure

  12. Cardiac injury evaluated by TTE in chronic phase

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

    Measured: Within 4-8 months after CO exposure

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

    Brain injury evaluated by brain MRI in CO poisoning

    Measured: Within 6 months after CO exposure

  14. Brain injury related to CO poisoning

    Brain injury evaluated by laboratory tests in CO poisoning

    Measured: Within 6 months after CO exposure

  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

    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

    Measured: Outcomes 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

    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

    Measured: Outcomes 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

    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

    Measured: Outcomes 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

    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

    Measured: Outcomes 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

    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

    Measured: Outcomes at 1 month after CO exposure

  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

    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

    Measured: Outcomes at 6 months after CO exposure

  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

    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

    Measured: Outcomes at 12 months after CO exposure

  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

    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

    Measured: Outcomes at 5 years after CO exposure

  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

    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

    Measured: Outcomes at 1 month after CO exposure

  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

    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

    Measured: Outcomes at 6 months after CO exposure

  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

    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

    Measured: Outcomes at 12 months after CO exposure

  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

    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

    Measured: Outcomes at 5 years after CO exposure

  27. Therapeutic response to drugs at 1 month

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

    Measured: At 1 month after CO exposure

  28. Therapeutic response to drugs at 6 months

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

    Measured: At 6 months after CO exposure

  29. Therapeutic response to drugs at 12 months

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

    Measured: At 12 months after CO exposure

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

    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

    Measured: At 1 month after CO exposure

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

    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

    Measured: At 6 months after CO exposure

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

    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

    Measured: At 12 months after CO exposure

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

    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

    Measured: At 5 years after CO exposure

  34. Organ injury related to CO poisoning

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

    Measured: Within 6 months after CO exposure

  35. Complications related to CO poisoning

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

    Measured: Within 6 months after CO exposure

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

    Effect of HBO for patient with delayed neurocognitive and psychological sequelae at 1 year after sequelae onset

    Measured: Within 1 year after delayed neurocognitive and psychological sequelae onset

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

    Effect of HBO for patient with delayed neurocognitive and psychological sequelae at 2 years after sequelae onset

    Measured: Within 2 years after delayed neurocognitive and psychological sequelae onset

  38. Validation of methods evaluating neurocognitive and psychological outcomes

    Validation of methods evaluating neurocognitive and psychological outcomes within 6 months

    Measured: Within 6 months after CO exposure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2020
  2. Study start29 Jul 2020
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04490317
Sponsor's protocol ID
CARE CO cohort
Status last verified
Jul 2024
First submitted
21 Jul 2020
Last updated
23 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ahn GJ, Lee S, Heo YW, Cha YS. Mortality Risks and Causes in Previous Carbon Monoxide Poisoning: A Nationwide Population-Based Cohort Study. Crit Care Med. 2024 Dec 1;52(12):1866-1876. doi: 10.1097/CCM.0000000000006414. Epub 2024 Sep 18.

    PubMed 39298511

Questions about this trial

What is this clinical trial studying?

An observational study of Carbon Monoxide Poisoning and Myocardial Injury, run by Wonju Severance Christian Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yong Sung Cha, MD (+82-33-741-1615, emyscha@yonsei.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapeutic response to HBO at 1 month (time frame: At 1 month after CO exposure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04490317, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.

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