Viewing Study NCT04215094


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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: Pan Jun
Organization:

Study Overview

Official Title: Role of Postoperative Fever, Serum Procalcitonin, C-reactive Protein and White Blood Cell Count in the Diagnosis of Intracranial Infection After Craniotomy
Status: UNKNOWN
Status Verified Date: 2020-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
Detailed Description: 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.

The 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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: