Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT04903405
Status:
UNKNOWN
Last Update Posted:
2021-05-26
First Post:
2021-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Function Monitoring and Immunotherapy in Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], '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': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-23', 'studyFirstSubmitDate': '2021-05-23', 'studyFirstSubmitQcDate': '2021-05-23', 'lastUpdatePostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Percentage of sepsis patients receiving immune function monitoring', 'timeFrame': '28 days'}, {'measure': 'Percentage of sepsis patients receiving immunotherapy', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Septic Shock']}, 'referencesModule': {'references': [{'pmid': '32636658', 'type': 'BACKGROUND', 'citation': 'Pei F, Zhang GR, Zhou LX, Liu JY, Ma G, Kou QY, He ZJ, Chen MY, Nie Y, Wu JF, Guan XD; China Critical Care Immunotherapy Research Group. Early Immunoparalysis Was Associated with Poor Prognosis in Elderly Patients with Sepsis: Secondary Analysis of the ETASS Study. Infect Drug Resist. 2020 Jun 30;13:2053-2061. doi: 10.2147/IDR.S246513. eCollection 2020.'}, {'pmid': '23327199', 'type': 'BACKGROUND', 'citation': 'Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.'}, {'pmid': '21933399', 'type': 'BACKGROUND', 'citation': 'Wu JF, Ma J, Chen J, Ou-Yang B, Chen MY, Li LF, Liu YJ, Lin AH, Guan XD. Changes of monocyte human leukocyte antigen-DR expression as a reliable predictor of mortality in severe sepsis. Crit Care. 2011;15(5):R220. doi: 10.1186/cc10457. Epub 2011 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'At present, the clinical studies of various anti-inflammatory drugs and immune-enhancing drugs show that immunotherapy will bring new hope for the treatment of sepsis. In order to further understand the current status of immunotherapy in China, this study aims to understand the current status and standardization of the use of sepsis immunosurveillance and immunotherapy in hospitals through a cross-sectional survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patient was diagnosed with sepsis or septic shock according to Sepsis 3.0', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with sepsis or septic shock according to Sepsis 3.0\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04903405', 'acronym': 'IMITS', 'briefTitle': 'Immune Function Monitoring and Immunotherapy in Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Immune Function Monitoring and Immunotherapy in Sepsis: a Cross-sectional Survey in China', 'orgStudyIdInfo': {'id': 'IMITS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention is involved in this study', 'armGroupLabels': ['Sepsis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jianfeng Wu', 'role': 'CONTACT', 'email': 'wujianf@mail.sysu.edu.cn', 'phone': '020-87755766-8453'}, {'name': 'Fei Pei', 'role': 'CONTACT', 'email': 'peif3@mail.sysu.edu.cn', 'phone': '020-87755766-8453'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Wu Jianfeng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}