Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT04850456
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2021-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The death rate of children', 'timeFrame': 'within 28 days after they discharged from PICU', 'description': 'The death rate of children in 28 days after their discharged from PICU'}, {'measure': 'length of stay in PICU', 'timeFrame': 'up to 28 days', 'description': 'Time from PICU admission to discharge'}], 'secondaryOutcomes': [{'measure': 'CD4+/CD8+', 'timeFrame': 'Within 3 to 15 days after the start of treatment', 'description': 'levels of peripheral blood subgroup of T lymphocyte (digital form)'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': 'Within 3 to 15 days after the start of treatment', 'description': 'C-reactive protein (digital form)'}, {'measure': 'IL-2R', 'timeFrame': 'Within 3 to 15 days after the start of treatment', 'description': 'The interleukin-2 receptor (digital form)'}, {'measure': 'TNF-alpha', 'timeFrame': 'Within 3 to 15 days after the start of treatment', 'description': 'Tumor necrosis factor alpha (digital form)'}, {'measure': 'Treg', 'timeFrame': 'Within 3 to 15 days after the start of treatment', 'description': 'levels of peripheral blood subgroup of T lymphocyte (digital form)'}, {'measure': 'IL-6', 'timeFrame': 'Within 3 to 15 days after the start of treatment', 'description': 'The interleukin-6 (digital form)'}, {'measure': 'IFN-gamma', 'timeFrame': 'Within 3 to 15 days after the start of treatment', 'description': 'Interferon gamma (digital form)'}, {'measure': 'Procalcitonin (digital form)', 'timeFrame': 'Within 3 to 15 days after the start of treatment', 'description': 'Procalcitonin (digital form)'}, {'measure': 'IL-10', 'timeFrame': 'Within 3 to 15 days after the start of treatment', 'description': 'The interleukin-10 (digital form)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Critical Illness', 'Inflammatory Storm', 'Gamma Globulin'], 'conditions': ['Critical Illness', 'Sepsis, Severe']}, 'descriptionModule': {'briefSummary': 'The inflammatory storm in critically ill patients releases cytokines, causing systemic immune damage, which may be an important cause of multiple organ failure and even death. Inflammatory storms exacerbate the deterioration of the disease in those children. Gamma globulin may be an effective option to control inflammatory storms. However, this preliminary result needs to be verified from reliable and representative RCTs. In our study, we conducted a retrospective study on the use of gamma globulin and an unused control group. At present, the indications of IVIG are mainly focused on the neuromuscular system and the blood system. We hope to establish a more appropriate and operable evaluation table for the suitability of gamma globulin for clinical use.', 'detailedDescription': 'In severe infective patients who survive the initial inflammatory storm, the immune response often evolves toward a state of immunosuppression, which contributes to increased mortality and severe secondary hospital-acquired infections. However, the role of gamma globulin therapy in patients with severe infection including sepsis and septic shock is discussed controversially. We intend to retrospectively analyze the efficacy and application evaluation of gamma globulin in severely infected children hospitalized in the intensive care unit. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record. It is expected to provide evaluation basis for clinicians to formulate treatment plans and clinical pharmacists for special comments on the clinical use of gamma globulin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '29 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children hospitalized in PICU of Children's Hospital of Fudan University\n* Children With Severe Infection Complicated With Inflammatory Storm\n\nExclusion Criteria:\n\n* discharge within 48 hours\n* patients without informed consent\n* incomplete clinical and demographic data"}, 'identificationModule': {'nctId': 'NCT04850456', 'briefTitle': 'Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Treatment Strategy of Human Gamma Globulin in Children With Severe Infection Complicated With Inflammatory Storm : A Cohort Study', 'orgStudyIdInfo': {'id': 'fdpicu-16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'trial group', 'description': 'Human Gamma Globulin'}, {'label': 'control group', 'description': 'conventional treatment'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoping Lu, MD', 'role': 'CONTACT', 'email': '13788904150@163.com', 'phone': '+86 18017590817'}], 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201102', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoping Lu', 'role': 'CONTACT', 'email': '13788904150@163.com', 'phone': '+86 18017590817'}], 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Guoping Lu, Doctor', 'role': 'CONTACT', 'email': '13788904150@163.com', 'phone': '13788904150'}, {'name': 'Yao Wang', 'role': 'CONTACT', 'email': 'y_wang@fudan.edu.cn', 'phone': '+86 13636547582'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}