Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-05 @ 5:56 PM
Study NCT ID:
NCT07134868
Status:
COMPLETED
Last Update Posted:
2025-08-21
First Post:
2024-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sepsis and Thiol-Disulfide Balance in Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2025-08-14', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic value of serum thiol-disulfide homeostasis parameters in sepsis', 'timeFrame': '2 monhts', 'description': 'Measurement of serum total thiol, native thiol, disulfide, reduced thiol, and oxidized thiol levels in patients with sepsis and healthy controls at the time of admission, and comparison between groups to evaluate diagnostic performance.'}], 'secondaryOutcomes': [{'measure': 'General Characteristics of All Participants', 'timeFrame': '1 week', 'description': 'Demographic data (age, gender, body mass index) were recorded.'}, {'measure': 'Correlation of inflammatory and biochemical markers with thiol-disulfide homeostasis in sepsis', 'timeFrame': '10 days', 'description': 'Initial blood samples collected from sepsis patients were analyzed to measure total thiol, native thiol, disulfide, reduced thiol, and oxidized thiol levels. These thiol-disulfide homeostasis parameters were then compared and correlated with standard laboratory inflammatory markers, including C-reactive protein (CRP), procalcitonin, and lactate, to evaluate their relationships.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diagnostic efficacy', 'Sepsis', 'Oxidative Stress', 'Emergency Department', 'Thiol- Disulfide Homeostasis'], 'conditions': ['Sepsis', 'Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to determine the effectiveness of thiol-disulfide homeostasis in predicting diagnosis and mortality in sepsis patients, and to compare it with other inflammatory markers.', 'detailedDescription': 'Sepsis is a serious illness with high mortality rates triggered by infection-associated pathogenesis involving oxidative stress dysfunction. This study aims to elucidate the diagnostic efficacy of changes in thiol-disulfide homeostasis, its predictive role in mortality, relationship with other inflammatory parameters in sepsis patients in emergency department.\n\nIn prospective, randomized controlled study, 50 patients diagnosed with sepsis according to the Sepsis-3 guidelines who presented emergency department were compared with a control group of 50 healthy volunteers. Thiol-disulfide homeostasis parameters, including total thiol, native thiol, disulfide levels, reduced thiol, oxidized thiol, and thiol oxidation-reduction ratios, were examined. Additionally, inflammatory blood parameters (C-reactive protein, procalcitonin, lactate) and mortality durations were compared with thiol-disulfide homeostasis.\n\nThe objective of this study was to examine the effectiveness of thiol-disulfide homeostasis in forecasting diagnosis and mortality in sepsis patients, and to compare it against other inflammatory markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 and above who met the diagnostic criteria were included in the study\n\nExclusion Criteria:\n\n* Who did not meet the criteria for sepsis diagnosis according to the quick Sequential Organ Failure Assessment score\n* Individuals with malignancy, acute coronary syndrome, acute cerebrovascular event, acute/chronic kidney/liver failure, rheumatologic diseases, febrile neutropenia, immunosuppressive disorders, corticosteroid use, and those\n* Individuals with a history of antibiotic use within the last week'}, 'identificationModule': {'nctId': 'NCT07134868', 'briefTitle': 'Sepsis and Thiol-Disulfide Balance in Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Sakarya University'}, 'officialTitle': 'The Diagnostic Efficacy of Thiol-Disulfide Homeostasis in Sepsis Patients', 'orgStudyIdInfo': {'id': 'SAU-ED-MA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sepsis Group', 'description': 'Consisted of patients diagnosed with sepsis (defined as those presenting to the emergency department with suspected infection and scoring two or higher on the quick Sequential Organ Failure Assessment scoring system according to the Sepsis-3 guidelines) and who agreed to participate in the study.', 'interventionNames': ['Diagnostic Test: Thiol- Disulfide Blood Sample Measurement']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Comprised of healthy volunteers who presented to the emergency department for any reason and agreed to participate in the study.'}], 'interventions': [{'name': 'Thiol- Disulfide Blood Sample Measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of thiol-disulfide homeostasis parameters and inflammatory markers from serum samples.', 'armGroupLabels': ['Sepsis Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54050', 'city': 'Sakarya', 'state': 'Adapazarı', 'country': 'Turkey (Türkiye)', 'facility': 'Sakarya University', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}], 'overallOfficials': [{'name': 'Mehmet Alacam, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sakarya University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sakarya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medicine Doctor', 'investigatorFullName': 'Mehmet Alaçam, MD', 'investigatorAffiliation': 'Sakarya University'}}}}