Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT04215094
Status:
UNKNOWN
Last Update Posted:
2020-10-23
First Post:
2019-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Diagnosis of Intracranial Infection After Craniotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2019-11-28', 'studyFirstSubmitQcDate': '2020-01-05', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the diagnosis of intracranial infection after craniotomy', 'timeFrame': 'up to 100 weeks', 'description': 'Intracranial infection are serious complications postoperatively in neurosurgical patients. Early identification of these complications is essential to minimize the mortality and moribidy. The aim of this study is observe the postoperative dynamic changes of body temperature (BT), procalcitonin (PCT), C-reactive protein (CRP), and white blood cell (WBC) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy of intracranial infection'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Procalcitonin', 'C-reactive protein', 'white blood cell count', 'intracranial infection'], 'conditions': ['Intracranial; Infection, Psychosis, Acute or Subacute']}, 'referencesModule': {'references': [{'pmid': '25892244', 'type': 'BACKGROUND', 'citation': 'Sughrue ME, Bonney PA, Choi L, Teo C. Early Discharge After Surgery for Intra-Axial Brain Tumors. World Neurosurg. 2015 Aug;84(2):505-10. doi: 10.1016/j.wneu.2015.04.019. Epub 2015 Apr 17.'}, {'pmid': '19604553', 'type': 'RESULT', 'citation': 'Dubey A, Sung WS, Shaya M, Patwardhan R, Willis B, Smith D, Nanda A. Complications of posterior cranial fossa surgery--an institutional experience of 500 patients. Surg Neurol. 2009 Oct;72(4):369-75. doi: 10.1016/j.surneu.2009.04.001. Epub 2009 Jul 14.'}, {'pmid': '26171888', 'type': 'RESULT', 'citation': 'Chidambaram S, Nair MN, Krishnan SS, Cai L, Gu W, Vasudevan MC. Postoperative Central Nervous System Infection After Neurosurgery in a Modernized, Resource-Limited Tertiary Neurosurgical Center in South Asia. World Neurosurg. 2015 Dec;84(6):1668-73. doi: 10.1016/j.wneu.2015.07.006. Epub 2015 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'Intracranial infection are serious complications postoperatively in neurosurgical patients. Early identification of these complications is essential to minimize the mortality and moribidy. The aim of this study is observe the postoperative dynamic changes of body temperature (BT), procalcitonin (PCT), C-reactive protein (CRP), and white blood cell (WBC) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy of intracranial infection.', 'detailedDescription': "Intracranial infection is a serious complications after neurosurgical operation. Early identification of intracranial infection is important so that, first, optimal treatment is initiated which may improves outcome, second, inappropriate antibiotic treatment and subsequent resistance are prevented, and third, it will promote shorter hospitalization and less cost. In several previous studies, the values of procalcitonin (PCT) and C-reactive protein (CRP) in predicting intracranial infection have been evaluated in neurosurgical patients. However, due to the limited number of studies, the results are not convincing enough and more investigations seems warranted to clarify their dynamic changes in neurosurgical patients without intracranial infection and their role in confirming the suspicion of intracranial infection or excluding intracranial infection from the differential diagnosis.\n\nThe aim of the investigator's study is to observe the postoperative dynamic changes of BT, PCT, CRP, and white blood cell (WBC) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy for rational decisions about antibiotic treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Postoperative intracranial infection is one of the most serious complications after neurosurgery. At present, there is no prospective study or recognized effective method for its early diagnosis. It is of great significance for a study about early diagnosis of postoperative intracranial infection,\n\nIn this study, the best diagnostic points of ROC curve will be constructed based on two statistical principles through retrospective study, and then the diagnostic value will be determined through prospective multicenter randomized controlled study. In the research, we will establish quality control system, risk control system and dynamic design to ensure the safety of research subjects and the quality of research results.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. craniotomy of brain tumor;\n2. no clinical manifestations of infection before operation;\n3. no other infection such as respiratory tract infection, urinary tract infection and deep vein catheter infection before the definite diagnosis of intracranial infection ;\n4. the patients had informed consent to enter the study.\n\nExclusion Criteria:\n\n1. blood system diseases,respiratory tract infection, urinary tract infection and deep vein catheter infection;\n2. malignant tumors with neuroendocrine characteristicsr;\n3. aspiration, pancreatitis, etc.'}, 'identificationModule': {'nctId': 'NCT04215094', 'briefTitle': 'Early Diagnosis of Intracranial Infection After Craniotomy', 'organization': {'class': 'OTHER', 'fullName': 'Southern Medical University, China'}, 'officialTitle': 'Role of Postoperative Fever, Serum Procalcitonin, C-reactive Protein and White Blood Cell Count in the Diagnosis of Intracranial Infection After Craniotomy', 'orgStudyIdInfo': {'id': 'SouthernMUC1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'infected group', 'description': 'Intracranial infection were diagnosed according to the Centers for Disease Control (CDC) definitions', 'interventionNames': ['Diagnostic Test: postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun']}, {'label': 'non-infected group', 'description': 'the postoperative recovery was uneventful with no infection', 'interventionNames': ['Diagnostic Test: postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun']}], 'interventions': [{'name': 'postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients in Intracranial Infection group were cured with antibiotic treatment', 'armGroupLabels': ['infected group', 'non-infected group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': "xi'an Zhang, MD, PhD", 'role': 'CONTACT', 'email': '48831443@qq.com'}, {'name': 'Junxiang Peng, MD,PHD', 'role': 'CONTACT', 'email': 'pjxlaozong@126.com'}], 'facility': 'Neurosurgery department, Nanfang hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': "Xi'an Zhang, doctor", 'role': 'CONTACT', 'email': '48831443@qq.com', 'phone': '+86-020-61641815'}, {'name': 'Junxiang Peng, doctor', 'role': 'CONTACT', 'email': 'pjxlaozong@126.com', 'phone': '+86-020-616418006'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pan Jun', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PHD, MD,Deputy director of Neurosurgery department', 'investigatorFullName': 'Pan Jun', 'investigatorAffiliation': 'Southern Medical University, China'}}}}