Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-25 @ 2:11 PM
Study NCT ID:
NCT03791866
Status:
UNKNOWN
Last Update Posted:
2019-01-03
First Post:
2018-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Th9/IL-9 and Early Enteral Nutrition in 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': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-31', 'studyFirstSubmitDate': '2018-12-21', 'studyFirstSubmitQcDate': '2018-12-31', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-d mortality', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Serum Th9 lymphocyte percentages', 'timeFrame': '7 days', 'description': 'Serum Th9 lymphocyte percentages'}, {'measure': 'Concentration of serum IL-9', 'timeFrame': '7 days', 'description': 'Concentration of serum IL-9'}, {'measure': 'Concentration of serum iFABP', 'timeFrame': '7 days', 'description': 'Concentration of serum iFABP'}, {'measure': 'Concentration of serum DAO', 'timeFrame': '7 days', 'description': 'Concentration of serum DAO'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Intestinal Mucosal Barrier', 'Th9 Cells', 'Enteral Nutrition']}, 'referencesModule': {'references': [{'pmid': '33941281', 'type': 'DERIVED', 'citation': 'Sun JK, Zhou J, Sun XP, Shen X, Zhu DM, Wang X, Zhou SM, Mu XW. Interleukin-9 promotes intestinal barrier injury of sepsis: a translational research. J Intensive Care. 2021 May 3;9(1):37. doi: 10.1186/s40560-021-00550-y.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to evaluate the roles of Th9/IL-9 in the mechanisms of early enteral nutrition (EEN) maintaining intestinal mucosal barrier in sepsis. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis. In addition, the investigators also aim to evaluate the effects of different proportions of target total enteral nutrition on the prognosis of sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of sepsis\n2. Within 3 days of sepsis onset before ICU admission\n3. No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission\n\nExclusion Criteria:\n\n1. Ileus\n2. Digestive tract hemorrhage\n3. Inflammatory bowel disease\n4. Abdominal hypertension (IAP \\>25mmHg)\n5. Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)\n6. Malnutrition or immunodeficiency\n7. Long-term use of hormones'}, 'identificationModule': {'nctId': 'NCT03791866', 'briefTitle': 'The Th9/IL-9 and Early Enteral Nutrition in Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'The Roles of Th9/IL-9 in the Mechanisms of Early Enteral Nutrition Maintaining Intestinal Mucosal Barrier in Sepsis', 'orgStudyIdInfo': {'id': 'YKK17102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '30% target total enteral nutrition', 'interventionNames': ['Other: Nutrition']}, {'type': 'EXPERIMENTAL', 'label': '60% target total enteral nutrition', 'interventionNames': ['Other: Nutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': '100% target total enteral nutrition', 'interventionNames': ['Other: Nutrition']}], 'interventions': [{'name': 'Nutrition', 'type': 'OTHER', 'description': 'Enteral nutrition', 'armGroupLabels': ['100% target total enteral nutrition', '30% target total enteral nutrition', '60% target total enteral nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Zhou', 'role': 'CONTACT', 'email': '565219791@qq.com', 'phone': '+8613913893984'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Jie Zhou', 'role': 'CONTACT', 'email': '565219791@qq.com', 'phone': '+8613913893984'}], 'overallOfficials': [{'name': 'Jia-Kui Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'XiangWang', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}