Safety and Efficacy of Ventricular Irrigation for Ventriculitis

Recruiting now · Not applicable

Conditions studied: Central Nervous System Infections

In brief

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.

Key facts

Study ID

NCT06358209

Run by

RenJi Hospital

People needed

310

Starts

2025-07-01

Expected to finish

2028-12-31

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shanghai Donglei Brain Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• South taihu hospital affiliated to huzhou college — Huzhou, Zhejiang, China (enrolling)
• Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai, Shanghai Municipality, China (enrolling)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China
• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China
• Zhongshan Hospital of Traditional Chinese Medicine — Zhongshan, Guangdong, China
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China
• Henan Provincial People's Hospital — Zhengzhou, Henan, China
• Xiangya Hospital of Central South University — Changsha, Hunan, China
• Jiangsu Province Hospital — Nanjing, Jiangsu, China
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
• 904 Hospital of the People's Liberation Army Joint Logistic Support Force — Wuxi, Jiangsu, China
• Affiliated Hospital of Yangzhou University — Yangzhou, Jiangsu, China
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
• The Fourth Affiliated Hospital of China Medical University — Shenyang, Liaoning, China
• The Second Affiliated Hospital of Air Force Medical University — Xi'an, Shaanxi, China
• Qilu Hospital of Shandong University — Jinan, Shandong, China
• Shanghai East Hospital — Shanghai, Shanghai Municipality, China
• Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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