Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT05136560
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2021-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2021-11-15', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28 day mortality', 'timeFrame': '28 days', 'description': 'death at 28 day'}], 'secondaryOutcomes': [{'measure': '90 day mortality', 'timeFrame': '90 days', 'description': 'death at 90 day'}, {'measure': 'Time to septic shock', 'timeFrame': 'up to 1 month, During hospital stay', 'description': 'Time to septic shock after enrollment'}, {'measure': 'Time to shock reversal', 'timeFrame': 'up to 1 month, During hospital stay', 'description': 'time required for shock reversal'}, {'measure': 'Administration of steroid according to guideline, yes or no', 'timeFrame': 'up to 1 month, During hospital stay', 'description': 'Need for additional steroid requirement according to the sepsis guideline'}, {'measure': 'ventilator free days', 'timeFrame': 'up to 3 month, During hospital stay', 'description': 'days independent from ventilator care'}, {'measure': 'continuous renal replacement therapy (CRRT)', 'timeFrame': 'up to 3 month, During hospital stay', 'description': 'requirement of CRRT'}, {'measure': 'Length of stay in intensive care unit (ICU)', 'timeFrame': 'up to 6 month, During hospital stay', 'description': 'Days spent in intensive care unit (ICU)'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'up to 6 month, During hospital stay', 'description': 'Days spent in hospital'}, {'measure': 'Delta SOFA sore on day 3 and 7', 'timeFrame': '7 days', 'description': 'Change of SOFA score on day 3 and day 7'}, {'measure': 'Superinfection', 'timeFrame': '28 days', 'description': 'secondary infection'}, {'measure': 'Gastrointestinal bleeding', 'timeFrame': '14 days', 'description': 'Gastrointestinal bleeding at any amount'}, {'measure': 'Hyperglycemia', 'timeFrame': '7 days', 'description': 'serum glucose \\>150 mg/dL'}, {'measure': 'Hypernatremia', 'timeFrame': '7 days', 'description': 'serum sodium \\>150mmol/L'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis, glucocorticoid'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '36116775', 'type': 'DERIVED', 'citation': 'Choi K, Park JE, Kim A, Hwang S, Bae J, Shin TG, Kim K. The DEXA-SEPSIS study protocol: a phase II randomized double-blinded controlled trial of the effect of early dexamethasone in high-risk sepsis patients. Clin Exp Emerg Med. 2022 Sep;9(3):246-252. doi: 10.15441/ceem.22.276. Epub 2022 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and efficacy of early administration of two different doses of dexamethasone in high risk septic patients.', 'detailedDescription': 'The septic adult patients of high risk would be enrolled in 2 emergency departments.\n\nSepsis would be defined by Sepsis-3 definition. High risk is defined as initial systolic blood pressure less than 90 mmHg or blood lactate level over 2 mmol/L.\n\nThe enrolled patients would be randomized to 3 groups: control, low dose dexamethasone (0.1 mg/kg iv), and high dose dexamethasone (0.2mg/kg iv).\n\nThe study drug is blinded and administered after enrollment for 2 days. Sample size would be 102, considering 10% of drop-out rate, allocating 30 patients to each groups.\n\nEfficacy would be evaluated as follows; 28 day and 90 day mortality, time to septic shock, time to shock reversal, administration of steroid according to guideline, ventilator free days, Continuous renal replacement, Length of stay in ICU or hospital, delta SOFA score on day 3 and day 7,\n\nSafety would be evaluated as follows; Superinfection Gastrointestinal bleeding, Hyperglycemia, Hypernatremia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sepsis defined by Sepsis-3 definition\n* Initial systolic blood pressure \\< 90mmHg or blood lactate level \\>2mmol/L\n\nExclusion Criteria:\n\n* advanced directive for "Do not resuscitation"\n* recent systemic administration of glucocorticoid (4 weeks)\n* recent systemic administration of chemotherapy (4 weeks)\n* recent systemic administration of immunosuppressant (4 weeks)\n* expected life less than 90 days\n* Transferred from other hospital\n* Sepsis diagnosed 24 hours after ED admission\n* Use of etomidate in ED\n* pregnant or on lactation\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT05136560', 'briefTitle': 'Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'CHA University'}, 'officialTitle': 'A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis', 'orgStudyIdInfo': {'id': 'DEXA-SEPSIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Placebo', 'description': 'normal saline'}, {'type': 'EXPERIMENTAL', 'label': 'low dose dexamethasone', 'description': '0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'high dose dexamethasone', 'description': '0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['JEIL Dexamethasone Injection'], 'description': 'Intervention drugs would be administered for 1 or 2 days.', 'armGroupLabels': ['high dose dexamethasone', 'low dose dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13488', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyuseok Kim, M.D, PhD', 'role': 'CONTACT', 'email': 'dreinstein70@gmail.com', 'phone': '+821047808321'}], 'facility': 'Bundang CHA hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Tae Gun Shin, M.D, PhD', 'role': 'CONTACT', 'email': 'taegunshin@skku.edu', 'phone': '+821099445806'}], 'facility': 'Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Kyuseok Kim, M.D, PhD', 'role': 'CONTACT', 'email': 'dreinstein70@gmail.com', 'phone': '+82-10-4780-8321'}], 'overallOfficials': [{'name': 'Kyuseok Kim, M.D, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bundang CHA Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHA University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Emergency Department', 'investigatorFullName': 'Kyuseok Kim', 'investigatorAffiliation': 'CHA University'}}}}