Prognostic Biomarkers in CO Poisoning

NCT05088005 | Completed

• 1 other identifier: CO-new biomarkers
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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).

Conditions

Carbon Monoxide Poisoning; Hyperbaric Oxygenation; Biomarkers

Outcome Measures

Primary Outcomes (2)

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

  At 1 day after HBO2

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

  At 7 days after HBO2

Secondary Outcomes (1)

• The prediction of poor neurocognitive outcome by serum biomarkers

  At 1 month after CO exposure

Study Arms (1)

Acute CO poisoning

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

Procedure: Hyperbaric oxygen therapy

Interventions

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.

Acute CO poisoning

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CO poisoned patients

You may qualify if:

• CO poisoned patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 21, 2021
• Study Start: January 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: February 28, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

KR (1)