Clinical trial NCT04490317: CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)
Official title: CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carbon Monoxide Poisoning
Myocardial Injury
Neurologic Deficits
Image, Body
Therapy
Prognostic Factors
Complications
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute CO poisoning

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.

Eligibility criteria: Inclusion Criteria:

* Acute CO poisoning

Exclusion Criteria:

* Declined to enrollment in the study

Primary outcomes:
measure: Therapeutic response to HBO at 1 month
timeFrame: At 1 month after CO exposure
measure: Therapeutic response to HBO at 6 months
timeFrame: At 6 months after CO exposure
measure: 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
timeFrame: Within 1 month after CO exposure
measure: 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
timeFrame: Within 1 month after CO exposure
measure: 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
timeFrame: Within 1 month after CO exposure
Secondary outcomes:
measure: Therapeutic response to HBO at 12 months
timeFrame: At 12 months after CO exposure
measure: Therapeutic response to TH combined with HBO at 1 month
timeFrame: At 1 month after CO exposure
measure: Therapeutic response to TH combined with HBO at 6 months
timeFrame: At 6 months after CO exposure
measure: Therapeutic response to TH combined with HBO at 12 months
timeFrame: At 12 months after CO exposure
measure: Therapeutic response to HBO according to presence of apolipoprotein E4 at 1 month
timeFrame: At 1 month after CO exposure
measure: Therapeutic response to HBO according to presence of apolipoprotein E4 at 6 months
timeFrame: At 6 months after CO exposure
measure: Therapeutic response to HBO according to presence of apolipoprotein E4 at 12 months after CO exposure
timeFrame: At 12 months after CO exposure
measure: Cardiac injury evaluated by cardiac MRI in acute phase
timeFrame: Within 1 month after CO exposure
measure: Cardiac injury evaluated by cardiac MRI in chronic phase
timeFrame: Follow-up cardiac MRI (at 4-8 months after CO exposure)
measure: Cardiac injury evaluated by cardiac CT
timeFrame: Within 1 month after CO exposure
measure: Cardiac injury evaluated by TTE in acute phase
timeFrame: Within 14 days after CO exposure
measure: Cardiac injury evaluated by TTE in chronic phase
timeFrame: Within 4-8 months after CO exposure
measure: Brain injury evaluated by brain imaging modality related to CO poisoning
timeFrame: Within 6 months after CO exposure
measure: Brain injury related to CO poisoning
timeFrame: Within 6 months after CO exposure
measure: 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
timeFrame: Outcomes at 1 month after CO exposure
measure: 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
timeFrame: Outcomes at 6 months after CO exposure
measure: 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
timeFrame: Outcomes at 12 months after CO exposure
measure: 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
timeFrame: Outcomes at 5 years after CO exposure
measure: 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
timeFrame: Outcomes at 1 month after CO exposure
measure: 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
timeFrame: Outcomes at 6 months after CO exposure
measure: 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
timeFrame: Outcomes at 12 months after CO exposure
measure: 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
timeFrame: Outcomes at 5 years after CO exposure
measure: 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
timeFrame: Outcomes at 1 month after CO exposure
measure: 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
timeFrame: Outcomes at 6 months after CO exposure
measure: 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
timeFrame: Outcomes at 12 months after CO exposure
measure: 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
timeFrame: Outcomes at 5 years after CO exposure
measure: Therapeutic response to drugs at 1 month
timeFrame: At 1 month after CO exposure
measure: Therapeutic response to drugs at 6 months
timeFrame: At 6 months after CO exposure
measure: Therapeutic response to drugs at 12 months
timeFrame: At 12 months after CO exposure
measure: Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 1 month
timeFrame: At 1 month after CO exposure
measure: Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 6 months
timeFrame: At 6 months after CO exposure
measure: Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 12 months
timeFrame: At 12 months after CO exposure
measure: Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 5 years
timeFrame: At 5 years after CO exposure
measure: Organ injury related to CO poisoning
timeFrame: Within 6 months after CO exposure
measure: Complications related to CO poisoning
timeFrame: Within 6 months after CO exposure
measure: Effect of HBO for delayed neurocognitive and psychological dysfunction at 1 year after onset
timeFrame: Within 1 year after delayed neurocognitive and psychological sequelae onset
measure: Effect of HBO for delayed neurocognitive and psychological dysfunction at 2 years after onset
timeFrame: Within 2 years after delayed neurocognitive and psychological sequelae onset
measure: Validation of methods evaluating neurocognitive and psychological outcomes
timeFrame: Within 6 months after CO exposure
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon
Study officials:
affiliation: Wonju Severance Christian Hospital
name: Yong Sung Cha, MD
role: PRINCIPAL_INVESTIGATOR
References: