The Clinical Character，Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.

Intracranial infection is one of the common clinical complications after neurosurgery, especially after external cerebrospinal fluid drainage. Postoperative intracranial infection has a very high incidence, and its incidence is about 0.34%-3.1%. Once infection occurs, it will directly affect the length of hospitalization, mortality and disability of postoperative patients. The pathogenic bacteria of postoperative intracranial infections include G-bacteria and G+ bacteria, and fungi. Common G+ bacteria are Staphylococcus aureus. Common G-bacteria are Acinetobacter baumannii, Klebsiella pneumoniae, and Pseudomonas aeruginosa Bacteria, Escherichia coli and so on. In recent years, studies have reported that postoperative intracranial infections of G-bacteria are gradually increasing. In the previous study of our research group, it was found that Acinetobacter baumannii and Klebsiella pneumoniae accounted for the top two pathogens of postoperative intracranial infections in ICU. In particular, the proportion of carbapenem-resistant G-bacteria has increased, which brings difficulty and challenge to the treatment and seriously affects the prognosis of patients. Different pathogen infections may lead to different prognosis of patients with intracranial infection after neurosurgery. With different pathogens as the starting point, there are few studies comparing the clinical features, risk factors, and prognosis of intracranial infections after neurosurgery. Therefore, it is great significant to explore and understand different pathogenic bacteria, risk factors, drug resistance, treatment options, and prognosis after neurosurgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections; Meningitis; Neurosurgery; Ventriculitis; Intracranial Infections
• Intervention / Treatment: Other

Detailed Description

1. To study the epidemiological distribution of pathogenic bacteria of intracranial infection after neurosurgery.
2. To study the risk factors of intracranial infection after neurosurgery (operations, type of external drainage tube, days of drainage tube , etc.).
3. To compare differences in clinical character，risks , treatment options, prognostic indicators between G+ bacterial infection group and G-infected bacterial group after neurosurgery.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: 林林 杜, PhD; Phone Number: 13738120095; Email: dulinlin@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A retrospective review of the Second Affiliated Hospital of Zhejiang University from January 2013 to May 2021, diagnosed patients with intracranial infection after surgery and positive for pathogenic microorganisms cultured in cerebrospinal fluid.

Description

Inclusion Criteria:

- Patients diagnosed with intracranial infection after surgery and positive pathogenic microorganisms cultured in cerebrospinal fluid

Exclusion Criteria:

• (1) < 18 years old, (2) Pregnant or lactating women, (3) fungus in CSF culture, (4) Clinical judgment is not intracranial infection, and CSF culture positive considers contaminating patients.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Gram-negative bacteria group; Gram-negative bacteria intracranial infection after neurosurgery
Gram-positive bacteria group; Gram-positive bacteria intracranial infection after neurosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	all-cause mortality	28 day mortality

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: 巍 崔, MD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Anticipated): June 10, 2021
• Primary Completion (Anticipated): August 30, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Meningitis; Bacterial Infections; Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections
• Other Study ID Numbers: 2021-0335

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No