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Recruiting NCT04490317

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

Observational Carbon Monoxide Poisoning Myocardial Injury Neurologic Deficits Image, Body

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardiac MRI, Hyperbaric oxygen therapy.
Who it may be relevant to
Registry conditions: Carbon Monoxide Poisoning, Myocardial Injury, Neurologic Deficits, Image, Body. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 test Cardiac 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
  • Procedure Hyperbaric oxygen therapy
    1. Hyperbaric oxygen therapy be used for CO poisoned patients 2. Therapeutic hypothermia be used for CO poisoned patients

Primary outcome measures

  • Therapeutic response to HBO at 1 month [Time frame: At 1 month after CO exposure]
  • Therapeutic response to HBO at 6 months [Time frame: 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 tests [Time frame: Within 1 month 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 [Time frame: Within 1 month after CO exposure]
  • 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]
Secondary outcome measures (12)
  • Therapeutic response to HBO at 12 months [Time frame: At 12 months after CO exposure]
  • 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 at 6 months [Time frame: At 6 months after CO exposure]
  • Therapeutic response to TH combined with HBO at 12 months [Time frame: At 12 months after CO exposure]
  • 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 at 6 months [Time frame: At 6 months after CO exposure]
  • Therapeutic response to HBO according to presence of apolipoprotein E4 at 12 months after CO exposure [Time frame: At 12 months after CO exposure]
  • Cardiac injury evaluated by cardiac MRI in acute phase [Time frame: Within 1 month after CO exposure]
  • Cardiac injury evaluated by cardiac MRI in chronic phase [Time frame: Follow-up cardiac MRI (at 4-8 months after CO exposure)]
  • Cardiac injury evaluated by cardiac CT [Time frame: Within 1 month after CO exposure]
  • Cardiac injury evaluated by TTE in acute phase [Time frame: Within 14 days after CO exposure]
  • Cardiac injury evaluated by TTE in chronic phase [Time frame: Within 4-8 months after CO exposure]

Eligibility criteria

Inclusion criteria

  • Acute CO poisoning

Exclusion criteria

  • Declined to enrollment in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Wonju Severance Christian Hospital — Wŏnju

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. PMID 39298511

Identifiers

NCT: NCT04490317 · CARE CO cohort

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗