Prognostic Biomarkers in CO Poisoning

Biomarkers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05088005
• Other study ID #: CO-new biomarkers
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: October 2021
• Source: Wonju Severance Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 28, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biomarkers
• Carbon Monoxide Poisoning
• Hyperbaric Oxygenation
• Poisoning

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon

Sponsors (2)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The prediction of poor neurocognitive outcome by serum biomarkers	The prediction of serum biomarkers for the patient's neurocognitive prognosis at 1 month	At 1 month after CO exposure