Prognostic Biomarkers in CO Poisoning

NCT ID: NCT05088005

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-02-28

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Carbon Monoxide Poisoning Hyperbaric Oxygenation Biomarkers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute CO poisoning

A diagnosis of CO poisoning was made according to medical history and carboxyhemoglobin \>5% (\>10% in smokers).

Hyperbaric oxygen therapy

Intervention Type 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.

Interventions

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Hyperbaric oxygen therapy

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* CO poisoned patients

Exclusion Criteria

1. age \< 19 years
2. a history of metabolic diseases
3. co-ingestion of drugs and alcohol, which may affect the biomarkers
4. discharge from the ED or transfer to another hospital
5. refusal to undergo HBO2
6. refusal to enroll in this study
7. lack of follow-up for assessing neurocognitive outcomes.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Wonju Severance Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yong Sung Cha

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CO-new biomarkers

Identifier Type: -

Identifier Source: org_study_id