An observational study in Intracranial; Infection, Psychosis, Acute or Subacute, sponsored by Pan Jun. Status unknown at 1 site in China. Open to participants aged 18 Years to 68 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-23.
Sponsored by Pan Jun · Observational
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 500 is above the median of 240 across 2,136 observational studies indexed under Infections.
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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,
In 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.
Exclusion Criteria:
Intracranial infection were diagnosed according to the Centers for Disease Control (CDC) definitions
Diagnostic Test: postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun
the postoperative recovery was uneventful with no infection
Diagnostic Test: postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun
All patients in Intracranial Infection group were cured with antibiotic treatment
the diagnosis of intracranial infection after craniotomy
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
Time frame: up to 100 weeks
Plan to share: No
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