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Completed

NCT Number: NCT05088005

Prognostic Biomarkers in CO Poisoning

Mitochondrial and oxidative stress participate in the pathogenic mechanisms of carbon monoxide (CO)-induced toxicity. Thus, serum indicators of mitochondrial and oxidative stress could be useful for predicting neurocognitive prognosis of post-CO poisoning. This prospective observational study of consecutive patients requiring hyperbaric oxygen therapy (HBO2) for acute CO poisoning measured serum biomarkers of mitochondrial (growth differentiation factor 15 [GDF15]; fibroblast growth factor 21 [FGF21]) and oxidative (8-Oxo-2'-deoxyguanosine [8-OHdG] and malondialdehyde [MDA]) stresses at arrival at the emergency department (0 h), and at 24 h and 7 days after HBO2 completion. We evaluated neurocognitive outcomes using the Global Deterioration Scale (GDS; favorable [1-3 points] or poor [4-7 points] outcomes).

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Key information

Conditions

Carbon Monoxide Poisoning Biomarkers Chemically-Induced Disorders Gas Poisoning Hyperbaric Oxygenation Poisoning

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

About this study

Mitochondrial and oxidative stress participate in the pathogenic mechanisms of carbon monoxide (CO)-induced toxicity. Thus, serum indicators of mitochondrial and oxidative stress could be useful for predicting neurocognitive prognosis of post-CO poisoning.

This prospective observational study of consecutive patients requiring hyperbaric oxygen therapy (HBO2) for acute CO poisoning measured serum biomarkers of mitochondrial (growth differentiation factor 15 [GDF15]; fibroblast growth factor 21 [FGF21]) and oxidative (8-Oxo-2'-deoxyguanosine [8-OHdG] and malondialdehyde [MDA]) stresses at arrival at the emergency department (0 h), and at 24 h and 7 days after HBO2 completion. We evaluated neurocognitive outcomes using the Global Deterioration Scale (GDS; favorable [1-3 points] or poor [4-7 points] outcomes).

Levels of serum mitochondrial (GDF15 and FGF21) and oxidative stress (8-OHdG and MDA) biomarkers pre- and post-HBO2 were compared, to assess whether HBO2 reduced stress. In addition, we evaluated whether the blood test results correlated with the patient's neurocognitive prognosis at 1 month.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • CO poisoned patients

Exclusion criteria

  • age < 19 years
  • a history of metabolic diseases
  • co-ingestion of drugs and alcohol, which may affect the biomarkers
  • discharge from the ED or transfer to another hospital
  • refusal to undergo HBO2
  • refusal to enroll in this study
  • lack of follow-up for assessing neurocognitive outcomes.

Treatment and study plan

Hyperbaric Oxygen Therapy

Procedure

Patients with any symptoms and signs were treated with HBO2. During the first HBO2, initial compression was performed to 2.8 atmospheres absolute (ATA) for 45 min, followed by 2.0 ATA for 60 min. If an additional HBO2 was possible within 24 h, then 2.0 ATA was administered for 90 min.

Primary outcomes

  1. Changes of serum biomarkers between pre-HBO2 and post HBO2

    Time frame: At 1 day after HBO2

    Levels of serum mitochondrial (GDF15 and FGF21) and oxidative stress (8-OHdG and MDA) biomarkers pre- and post-HBO2 were compared, to assess whether HBO2 reduced stress.

  2. Changes of serum biomarkers between pre-HBO2 and post HBO2

    Time frame: At 7 days after HBO2

    Levels of serum mitochondrial (GDF15 and FGF21) and oxidative stress (8-OHdG and MDA) biomarkers pre- and post-HBO2 were compared, to assess whether HBO2 reduced stress.

Secondary outcomes

  1. The prediction of poor neurocognitive outcome by serum biomarkers

    Time frame: At 1 month after CO exposure

    The prediction of serum biomarkers for the patient's neurocognitive prognosis at 1 month

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Official study title

Prognostic Biomarkers of Mitochondrial and Oxidative Stress in Acute Carbon Monoxide Poisoning: Prospective Hyperbaric Oxygen Therapy Intervention Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2021
Registry last updated
Oct 21, 2021

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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