Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT04627220
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2020-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Arterial Oxygen Parameters on Antioxidant Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-07', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-07', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of oxidative damage', 'timeFrame': '48 hours after operation', 'description': "To measure the degree of oxidative damage in the patient's blood at different oxygen values used in cardiac bypass surgeries with thiol disulfide homeostasis and ischemia-modified albumin at times determined."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiovascular surgery', 'antioxidant', 'tiyol-disülfid homeostasis', 'ischemia modified albumin'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'We aimed to measure the changes in your blood values caused by different but safe oxygen values used by us during your heart surgery under laboratory conditions.', 'detailedDescription': 'Hyperoxia is often preferred due to the risk of tissue hypoxia that may develop in cardiac surgery. It is thought that with hyperoxemia, ischemia reperfusion damage increases, microcirculation is impaired and tissue oxygenation is impaired.Oxidative damage occurs in cases of increased oxidative stress and impaired antioxidant balance.It was aimed to investigate oxidative damage by recording modified albumin and thiol disulfide in blood simultaneously by recording arterial oxygen levels at determined times during cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '128 patients scheduled for cardiac surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient scheduled for cardiac surgery\n* ASA\\>3\n* Aged 18-75 years\n\nExclusion Criteria:\n\n* those with valvular disease\n* EF\\<%40\n* BMI\\>40 kg/m2\n* presence of arrhythmia that impairs hemodynamics\n* previous history of cerebrovascular\n* diagnosed with end-stage organ failure'}, 'identificationModule': {'nctId': 'NCT04627220', 'briefTitle': 'The Effect of Arterial Oxygen Parameters on Antioxidant Parameters', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'The Effect of Arterial Oxygen Levels on Thiol Disulfide Homeostasis and Ischemia Modified Albumin in Coronary Artery Bypass Surgery', 'orgStudyIdInfo': {'id': 'Bursa High Education Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1', 'description': 'Group 1: Pressure of arterial oxygen\\> 200 mmHg during the coronary surgery', 'interventionNames': ['Diagnostic Test: taken venous sample']}, {'label': 'group 2', 'description': 'Group 2: Pressure of arterial oxygen\\<200 mmHg and \\>80 mmHg during the coronary surgery', 'interventionNames': ['Diagnostic Test: taken venous sample']}], 'interventions': [{'name': 'taken venous sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Venous blood samples taken during the operation and at the 48th hour after the operation will be examined after appropriate procedures.', 'armGroupLabels': ['group 1', 'group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60160', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Ümran K Karaca, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Tuğba O Onur, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Şeyda Ö Özgünay, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Filiz A Ata, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Canan Y Yılmaz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Şermin E Eminoğlu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Halil Erkan S Sayan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Yasemin Ü Üstündağ, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Anıl O Onur, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Umran Karaca', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}