Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 12:04 PM
Study NCT ID:
NCT05088850
Status:
UNKNOWN
Last Update Posted:
2021-10-22
First Post:
2021-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Early Prediction of Sepsis in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-19', 'studyFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2021-10-19', 'lastUpdatePostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'confidence index of sepsis occurrence', 'timeFrame': 'sepsis occurrence in five hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prediction of Sepsis in Critical Patients']}, 'referencesModule': {'references': [{'pmid': '36581881', 'type': 'DERIVED', 'citation': 'Chen Q, Li R, Lin C, Lai C, Chen D, Qu H, Huang Y, Lu W, Tang Y, Li L. Transferability and interpretability of the sepsis prediction models in the intensive care unit. BMC Med Inform Decis Mak. 2022 Dec 29;22(1):343. doi: 10.1186/s12911-022-02090-3.'}]}, 'descriptionModule': {'briefSummary': 'Sepsis is a vital issue in critical care medicine, and early detection and intervention are key to survival. We aimed to establish an early warning system for sepsis based on a data integration platform that can be implemented in the ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients that were admitted into the ICU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who met all of the following criteria were included in the case group:\n\n1. At least 14 years old.\n2. Sepsis onset at least 5 hours after ICU admission.\n3. Sepsis onset is the first instance since admission to the hospital.\n\nExclusion Criteria:\n\nPatients meeting all of the following criteria were included in the control group:\n\n1. At least 14 years old.\n2. Patients staying in ICU for at least 5 hours and have not had sepsis in this time.\n3. Patients without ICD-9 codes for sepsis (785·52, 995·91, 995·92).\n4. SOFA score change is not more than 1 point in an arbitrary continuous 72 hours in the ICU stay.'}, 'identificationModule': {'nctId': 'NCT05088850', 'briefTitle': 'The Early Prediction of Sepsis in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'The Early Prediction of Sepsis Occurrence in ICU', 'orgStudyIdInfo': {'id': '20211014LILEI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-sepsis', 'interventionNames': ['Other: no intervention']}, {'label': 'sepsis', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['non-sepsis', 'sepsis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ranran Li, PhD', 'role': 'CONTACT', 'email': 'rebecca1009@hotmail.com', 'phone': '18317059746'}], 'facility': 'ICU, Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ranran Li, PhD', 'role': 'CONTACT', 'email': 'rebecca1009@hotmail.com', 'phone': '18317059746'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'lei li', 'investigatorAffiliation': 'Ruijin Hospital'}}}}