Early Diagnosis of Intracranial Infection After Craniotomy

Sponsor

Pan Jun (Other)

Overall Status

Recruiting

CT.gov ID

NCT04215094

Collaborator

(none)

500

Enrollment

Location

18.6

Anticipated Duration (Months)

26.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial; Infection, Psychosis, Acute or Subacute	Diagnostic Test: postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun

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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Role of Postoperative Fever, Serum Procalcitonin, C-reactive Protein and White Blood Cell Count in the Diagnosis of Intracranial Infection After Craniotomy

Actual Study Start Date :

Jan 12, 2020

Anticipated Primary Completion Date :

Jul 12, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
infected group 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 All patients in Intracranial Infection group were cured with antibiotic treatment
non-infected group 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

Arm

Intervention/Treatment

infected group

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

All patients in Intracranial Infection group were cured with antibiotic treatment

non-infected group

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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