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Early Diagnosis of Intracranial Infection After Craniotomy

P

Pan Jun

Status

Unknown

Conditions

Intracranial; Infection, Psychosis, Acute or Subacute

Treatments

Diagnostic Test: postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun

Study type

Observational

Funder types

Other

Identifiers

NCT04215094
SouthernMUC1

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 68 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Xi'an Zhang, doctor; Junxiang Peng, doctor

Data sourced from clinicaltrials.gov

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