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Clinical Trials in China / NCT06358209
Recruiting Not applicable

Safety and Efficacy of Ventricular Irrigation for Ventriculitis

NCT06358209 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Not applicable
Started
2025-07-01
Last updated
2026-09-10

Condition(s) studied

Central Nervous System Infections

Investigational drug(s) / intervention(s)

Ventricular irrigation

Ventricular irrigation: Catheter ventricular irrigation can be employed by various forms. Lavage is performed with with each time at least 200ml of saline. Aside from lavage sessions, the lavage is paused, but continuous CSF drainage remains open.

Study summary

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 ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with ventriculitis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Age 18-65 years old; * CSF is purulent (it appears cloudy or yellow) and white blood cell count over 1000×10\^6/L. * Fever (\>38.0°C) * Meet at least one of the following: 1. Patient has organism(s) identified from CSF by a culture or non-culture based microbiologic testing method; 2. Cranial CT or MRI indicating intraventricular floccule or pus. * With consent form Exclusion Criteria: * With GCS score of 3 * With unstable vital signs such as no spontaneous breathing and blood pressure maintenance drugs * With severe propensity for bleeding (Such as coagulation dysfunction, active bleeding, etc.), and unable to tolerate the surgical procedures or operations related to ventricular irrigation treatment. * Pregnant or lactating women

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
The First Affiliated Hospital of University of Science and Technology of China Hefei Anhui Not Yet Recruiting
The Second People's Hospital of Anhui Province Hefei Anhui Not Yet Recruiting
The First Affiliated Hospital of Wannan Medical College Wuhu Anhui Not Yet Recruiting
Xuanwu Hospital Capital Medical University Beijing Beijing Municipality Not Yet Recruiting
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian Not Yet Recruiting
Nanfang Hospital, Southern Medical University Guangzhou Guangdong Not Yet Recruiting
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong Not Yet Recruiting
Shenzhen Second People's Hospital Shenzhen Guangdong Not Yet Recruiting
Zhongshan Hospital of Traditional Chinese Medicine Zhongshan Guangdong Not Yet Recruiting
The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Not Yet Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Not Yet Recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei Recruiting
Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Not Yet Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Not Yet Recruiting
Affiliated Hospital of Nantong University Nantong Jiangsu Not Yet Recruiting
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Not Yet Recruiting
904 Hospital of the People's Liberation Army Joint Logistic Support Force Wuxi Jiangsu Not Yet Recruiting
Affiliated Hospital of Yangzhou University Yangzhou Jiangsu Not Yet Recruiting
Ganzhou People's Hospital Ganzhou Jiangxi Not Yet Recruiting
The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi Not Yet Recruiting
The Fourth Affiliated Hospital of China Medical University Shenyang Liaoning Not Yet Recruiting
The Second Affiliated Hospital of Air Force Medical University Xi'an Shaanxi Not Yet Recruiting
Qilu Hospital of Shandong University Jinan Shandong Not Yet Recruiting
Renji Hospital, School of Medicine, Shanghai Jiaotong University Shanghai Shanghai Municipality Recruiting
Shanghai Donglei Brain Hospital Shanghai Shanghai Municipality Recruiting
Shanghai East Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai Tenth People's Hospital Shanghai Shanghai Municipality Not Yet Recruiting
The Second Affiliated Hospital of Naval Medical University Shanghai Shanghai Municipality Not Yet Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Not Yet Recruiting
Inner Mongolia People's Hospital Hohhot The Nei Monggol Autonomous Region Not Yet Recruiting
The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang Uygur Autonomous Region Not Yet Recruiting
First Affiliated Hospital of Zhejiang University Hangzhou Zhejiang Not Yet Recruiting
South taihu hospital affiliated to huzhou college Huzhou Zhejiang Recruiting
The affiliated people's hospital of ningbo university Ningbo Zhejiang Not Yet Recruiting

More RenJi Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06358209 on ClinicalTrials.gov ↗ ← All trials in China