Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-09 @ 8:52 AM
Study NCT ID:
NCT05088005
Status:
COMPLETED
Last Update Posted:
2021-10-21
First Post:
2021-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Biomarkers in CO Poisoning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002249', 'term': 'Carbon Monoxide Poisoning'}], 'ancestors': [{'id': 'D005739', 'term': 'Gas Poisoning'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-08', 'studyFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2021-10-08', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of serum biomarkers between pre-HBO2 and post HBO2', 'timeFrame': 'At 1 day after HBO2', 'description': '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.'}, {'measure': 'Changes of serum biomarkers between pre-HBO2 and post HBO2', 'timeFrame': 'At 7 days after HBO2', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The prediction of poor neurocognitive outcome by serum biomarkers', 'timeFrame': 'At 1 month after CO exposure', 'description': "The prediction of serum biomarkers for the patient's neurocognitive prognosis at 1 month"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carbon Monoxide Poisoning', 'Hyperbaric Oxygenation', 'Biomarkers']}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': "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.\n\nThis 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).\n\nLevels 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'CO poisoned patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CO poisoned patients\n\nExclusion Criteria:\n\n1. age \\< 19 years\n2. a history of metabolic diseases\n3. co-ingestion of drugs and alcohol, which may affect the biomarkers\n4. discharge from the ED or transfer to another hospital\n5. refusal to undergo HBO2\n6. refusal to enroll in this study\n7. lack of follow-up for assessing neurocognitive outcomes.'}, 'identificationModule': {'nctId': 'NCT05088005', 'briefTitle': 'Prognostic Biomarkers in CO Poisoning', 'organization': {'class': 'OTHER', 'fullName': 'Wonju Severance Christian Hospital'}, 'officialTitle': 'Prognostic Biomarkers of Mitochondrial and Oxidative Stress in Acute Carbon Monoxide Poisoning: Prospective Hyperbaric Oxygen Therapy Intervention Study', 'orgStudyIdInfo': {'id': 'CO-new biomarkers'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute CO poisoning', 'description': 'A diagnosis of CO poisoning was made according to medical history and carboxyhemoglobin \\>5% (\\>10% in smokers).', 'interventionNames': ['Procedure: Hyperbaric oxygen therapy']}], 'interventions': [{'name': 'Hyperbaric oxygen therapy', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Acute CO poisoning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26426', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wonju Severance Christian Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Foundation of Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yong Sung Cha', 'investigatorAffiliation': 'Wonju Severance Christian Hospital'}}}}