RecruitingNot ApplicableNCT06358209

Safety and Efficacy of Ventricular Irrigation for Ventriculitis

Safety and Efficacy of Ventricular Irrigation for Ventriculitis: a Randomized Controlled Trial


Sponsor

RenJi Hospital

Enrollment

310 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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

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Interventions

PROCEDUREVentricular 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.


Locations(35)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

The Second People's Hospital of Anhui Province

Hefei, Anhui, China

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

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

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 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

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Shanghai Donglei Brain Hospital

Shanghai, Shanghai Municipality, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Inner Mongolia People's Hospital

Hohhot, The Nei Monggol Autonomous Region, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, China

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

South taihu hospital affiliated to huzhou college

Huzhou, Zhejiang, China

The affiliated people's hospital of ningbo university

Ningbo, Zhejiang, China

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