Early Diagnosis of Intracranial Infection After Craniotomy

Intracranial; Infection, Psychosis, Acute or Subacute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04215094
• Other study ID #: SouthernMUC1
• Status: Recruiting
• Start date: January 12, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2020
• Source: Southern Medical University, China
• Contact: Xi'an Zhang, doctor
• Phone: +86-020-61641815
• Email: 48831443[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 1, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Intracranial; Infection, Psychosis, Acute or Subacute

Intervention

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

Locations

Country	Name	City	State
China	Neurosurgery department, Nanfang hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Pan Jun

Country where clinical trial is conducted

China, 

References & Publications (3)

Chidambaram S, Nair MN, Krishnan SS, Cai L, Gu W, Vasudevan MC. Postoperative Central Nervous System Infection After Neurosurgery in a Modernized, Resource-Limited Tertiary Neurosurgical Center in South Asia. World Neurosurg. 2015 Dec;84(6):1668-73. doi: — View Citation

Dubey A, Sung WS, Shaya M, Patwardhan R, Willis B, Smith D, Nanda A. Complications of posterior cranial fossa surgery--an institutional experience of 500 patients. Surg Neurol. 2009 Oct;72(4):369-75. doi: 10.1016/j.surneu.2009.04.001. Epub 2009 Jul 14. — View Citation

Sughrue ME, Bonney PA, Choi L, Teo C. Early Discharge After Surgery for Intra-Axial Brain Tumors. World Neurosurg. 2015 Aug;84(2):505-10. doi: 10.1016/j.wneu.2015.04.019. Epub 2015 Apr 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 100 weeks