Clinical trial NCT05088005: Prognostic Biomarkers in CO Poisoning
Official title: Prognostic Biomarkers of Mitochondrial and Oxidative Stress in Acute Carbon Monoxide Poisoning: Prospective Hyperbaric Oxygen Therapy Intervention Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carbon Monoxide Poisoning
Hyperbaric Oxygenation
Biomarkers
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2021-10-21
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CO poisoned patients

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of serum biomarkers between pre-HBO2 and post HBO2
timeFrame: At 1 day after HBO2
measure: Changes of serum biomarkers between pre-HBO2 and post HBO2
timeFrame: At 7 days after HBO2
Secondary outcomes:
measure: The prediction of poor neurocognitive outcome by serum biomarkers
timeFrame: At 1 month after CO exposure
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon
Study officials:
References: