Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-04 @ 8:55 AM
Study NCT ID:
NCT02883218
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis Patients
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood, serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-19', 'studyFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Th2/Th1 upon enrollment', 'timeFrame': 'Day 0 after enrollment for community-acquired severe sepsis group and Day 0 after enrollment for the non-severe sepsis patients and heathy control group', 'description': 'The blood samples were collected for T helper 1 cells and T helper 2 cells populations measured by flow cytometry. All groups are needed.'}, {'measure': 'Th2/Th1 on Day 3', 'timeFrame': 'Day 3 after enrollment for community-acquired severe sepsis group', 'description': 'populations measured by flow cytometry. Only community-acquired severe sepsis group is needed.'}, {'measure': 'Th2/Th1 on Day 7', 'timeFrame': 'Day 7 after enrollment for community-acquired severe sepsis group', 'description': 'populations measured by flow cytometry. Only community-acquired severe sepsis group is needed.'}], 'secondaryOutcomes': [{'measure': '28-day mortality for community-acquired severe sepsis group', 'timeFrame': '28-day'}, {'measure': 'ICU-acquired infection for community-acquired severe sepsis group', 'timeFrame': '28-day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['immunosuppression', 'community-acquired sepsis', 'mortality'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '30813927', 'type': 'DERIVED', 'citation': 'Xue M, Xie J, Liu L, Huang Y, Guo F, Xu J, Yang Y, Qiu H. Early and dynamic alterations of Th2/Th1 in previously immunocompetent patients with community-acquired severe sepsis: a prospective observational study. J Transl Med. 2019 Feb 27;17(1):57. doi: 10.1186/s12967-019-1811-9.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the dynamic alterations of Th2/Th1 for the prediction of clinical immunity and how it was related to 28 day-prognosis and ICU-acquired infections among critically ill patients of community-acquired severe sepsis with new onset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We enroll patients with community-acquired severe sepsis and then the patients admitted to ICU without the diagnosis of severe sepsis as ICU control group, and the heathy volunteers as healthy control group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'For community-acquired severe sepsis group:\n\nInclusion Criteria:\n\n* at least 18 years of age and no more than 90 years of age\n* sepsis was defined according to consensus criteria\n* diagnosis of sepsis and complicatied with organ dysfunction no longer than 48 h\n* provided written informed consent.\n\nExclusion Criteria:\n\n* diagnosis of hematological,immunological disease or cancer\n* treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization\n\nFor non-severe sepsis ICU control group:\n\nInclusion Criteria:\n\n* at least 18 years of age and no more than 90 years of age\n* without diagnosis of sepsis and admitted to ICU\n* provided written informed consent.\n\nExclusion Criteria:\n\n* diagnosis of hematological,immunological disease or cancer\n* treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization\n\nFor healthy control group:\n\nInclusion Criteria:\n\n* at least 18 years of age and no more than 90 years of age\n* provided written informed consent.\n\nExclusion Criteria:\n\n* diagnosis of hematological,immunological disease or cancer\n* treatment with chemotherapy agents or corticosteroids within 6 months prior to enrollment'}, 'identificationModule': {'nctId': 'NCT02883218', 'briefTitle': 'Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis', 'orgStudyIdInfo': {'id': '2014ZDSYLL087.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Comunity-acquired severe sepsis patients', 'description': 'Patients with new-onset community-acquired severe sepsis within 24h without confounding factors in immune status'}, {'label': 'Non-severe sepsis patients', 'description': 'Patients between 18 and 90 years of age and be admitted to the ICU without a diagnosis of severe sepsis.'}, {'label': 'Healthy controls', 'description': 'Heathy vonlunteers between 18 and 90 years of age.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jianfeng Xie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Jianfeng Xie', 'investigatorAffiliation': 'Southeast University, China'}}}}