Viewing Study NCT05088005


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Study NCT ID: NCT05088005
Status: COMPLETED
Last Update Posted: 2021-10-21
First Post: 2021-10-08
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Prognostic Biomarkers in CO Poisoning
Sponsor: Wonju Severance Christian Hospital
Organization:

Study Overview

Official Title: Prognostic Biomarkers of Mitochondrial and Oxidative Stress in Acute Carbon Monoxide Poisoning: Prospective Hyperbaric Oxygen Therapy Intervention Study
Status: COMPLETED
Status Verified Date: 2021-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: