protocolSection identificationModule nctId: NCT06358209, orgStudyIdInfo id: LY2024-045-B, briefTitle: Safety and Efficacy of Ventricular Irrigation for Ventriculitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-05-30, completionDateStruct date: 2026-05-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, collaborators name: Southern Medical University, China, collaborators name: First Affiliated Hospital of Zhejiang University, collaborators name: 904 Hospital of the People's Liberation Army Joint Logistic Support Force, collaborators name: Shenzhen Second People's Hospital, collaborators name: First Affiliated Hospital of Wannan Medical College, collaborators name: Huashan Hospital, descriptionModule briefSummary: Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Currently, the treatment for ventriculitis is challenging, with poor prognosis. The mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Even among survivors, over 60% suffer from a variety of neurological sequelae, including cognitive impairment, gait disturbances, paralysis, behavioral disorders, and epilepsy.Currently, treatments for ventriculitis recommended by guidelines primarily focus on the selection and administration of antibiotics, while the effects of surgical interventions have not been fully elucidated. In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques may accelerate the control of ventricular infection, mitigate damage to the central nervous system caused by infections, improve the prognosis of ventriculitis, and reduce complications such as hydrocephalus. However, current studies are still relatively scarce, and mostly case reports and retrospective studies. High-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis.This multicenter randomized controlled trial aims to explore the safety and effectiveness of ventricular irrigation compared to conventional treatment for severe ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with severe ventriculitis., conditionsModule conditions: Central Nervous System Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Ventricular irrigation, outcomesModule primaryOutcomes measure: Mortality rate, secondaryOutcomes measure: GOSE, secondaryOutcomes measure: CRS-R, secondaryOutcomes measure: DRS, secondaryOutcomes measure: mRS, secondaryOutcomes measure: Microbial culture, secondaryOutcomes measure: CSF glucose, secondaryOutcomes measure: CSF protein, secondaryOutcomes measure: CSF WBC count, secondaryOutcomes measure: Length of stay, otherOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Wannan Medical College, city: Wuhu, state: Anhui, country: China, contacts name: Xuefei Shao, Dr, role: CONTACT, geoPoint lat: 31.33728, lon: 118.37351, locations facility: Zhujiang Hospital of Southern Medical University, city: Guangzhou, state: Guangdong, country: China, contacts name: Qinghua Wang, Dr, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Shenzhen Second People's Hospital, city: Shenzhen, state: Guangdong, country: China, contacts name: Xianjian Huang, Dr, role: CONTACT, geoPoint lat: 22.54554, lon: 114.0683, locations facility: 904 Hospital of the People's Liberation Army Joint Logistic Support Force, city: Wuxi, state: Jiangsu, country: China, contacts name: Likun Yang, Dr, role: CONTACT, geoPoint lat: 31.56887, lon: 120.28857, locations facility: Huashan Hospital, city: Shanghai, state: Shanghai, country: China, contacts name: Jin Hu, Dr, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University, city: Shanghai, state: Shanghai, country: China, contacts name: Jiyao Jiang, Dr, role: CONTACT, phone: 021-68383729, email: jiyaojiang@126.com, contacts name: Junfeng Feng, Dr, role: CONTACT, phone: 13611860825, email: fengjfmail@163.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: First Affiliated Hospital of Zhejiang University, city: Hangzhou, state: Zhejiang, country: China, contacts name: Xiaofeng Yang, Dr, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False