Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 6:28 AM
Study NCT ID:
NCT06265493
Status:
COMPLETED
Last Update Posted:
2024-09-24
First Post:
2024-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Infectious Complications Calculator for Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-21', 'studyFirstSubmitDate': '2024-02-11', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Infectious Complications Calculator for Elderly Patients', 'timeFrame': 'January 2012 - August 2018', 'description': 'A Derivation and External Validation of Prediction Models based on two centers large sample'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative infectious complications', 'elderly patients', 'retrospective study', 'prediction model', 'calculator'], 'conditions': ['Postoperative Infection', 'Geriatrics', 'Prediction']}, 'descriptionModule': {'briefSummary': 'The investigators established a first-ever convenient scoring system for clinicians to assess the risk of Postoperative infectious complications (PICs) for elderly patients. Our scoring system can aid in the early detection of potential risks for postoperative infections. Higher-score patients were more likely to experience postoperative infections.', 'detailedDescription': "Background:\n\nPostoperative infectious complications (PICs) are related to increased morbidity, mortality, and costs, especially in elderly patients. However, published prediction models of PICs are rarely based on elderly patients.\n\nObjective:\n\nThe study wanted to identify practical and valuable variables that could be used to predict postoperative infections and establish a convenient scoring system for clinicians to assess the risk of such conditions in elderly patients.\n\nMethods： Data from 2 population-based cohorts of elderly patients undergoing non-cardiac and non-neurology surgery were used to derive and validate multivariable logistic regression models. The risk prediction models were derived from 37230 patients hospitalized in the First Medical Center of the Chinese PLA General Hospital (January 2012 - August 2018). The risk prediction models were externally validated with data from a cohort of 10252 patients hospitalized in Henan Provincial People's Hospital (November 2014 to May 2022)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 37230 participants were included in the derivation and internal validation cohorts (29785 in the derivation cohort and 7445 in the internal validation cohort).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥ 65 years and\n2. patients undergoing surgery with anesthesia.\n\nExclusion Criteria:\n\n1. patients undergoing neurosurgery or cardiac surgery,\n2. preoperative infectious diseases, and\n3. patients with ≥50% of data missing.'}, 'identificationModule': {'nctId': 'NCT06265493', 'briefTitle': 'Postoperative Infectious Complications Calculator for Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Postoperative Infectious Complications Calculator for Elderly Patients--A Derivation and External Validation of Prediction Models Based on Two Centers Large Sample', 'orgStudyIdInfo': {'id': 'PLAGH-AOC-L02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'derivation cohort', 'description': '29785 in the derivation cohort'}, {'label': 'internal validation cohort', 'description': '7445 in the internal validation cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Weidong Mi, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weidong Mi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Anesthesiology, The First Medical Center', 'investigatorFullName': 'Weidong Mi', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}