Early Diagnosis of Intracranial Infection After Craniotomy

• Conditions: Intracranial; Infection, Psychosis, Acute or Subacute
• Interventions: Diagnostic Test: postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun

• Registration Number: NCT04215094
• Lead Sponsor: Pan Jun

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 Timeline

• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2020-01-05
• Study First Posted: 2020-01-09
• Study Start: 2020-01-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23
• Primary Completion: 2021-07-12
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. craniotomy of brain tumor;
2. no clinical manifestations of infection before operation;
3. no other infection such as respiratory tract infection, urinary tract infection and deep vein catheter infection before the definite diagnosis of intracranial infection ;
4. the patients had informed consent to enter the study.

Exclusion Criteria

1. blood system diseases,respiratory tract infection, urinary tract infection and deep vein catheter infection;
2. malignant tumors with neuroendocrine characteristicsr;
3. aspiration, pancreatitis, etc.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-infected group	postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun	the postoperative recovery was uneventful with no infection
infected group	postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun	Intracranial infection were diagnosed according to the Centers for Disease Control (CDC) definitions

Primary Outcome Measures

Name	Time	Method
the diagnosis of intracranial infection after craniotomy	up to 100 weeks	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

Trial Locations

Locations (1)

Neurosurgery department, Nanfang hospital; 🇨🇳 Guangzhou, Guangdong, China