Safety and Efficacy of Ventricular Irrigation for Ventriculitis

Last updated: February 23, 2026
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Ventricular irrigation

Clinical Study ID

NCT06358209
LY2024-045-B
  • Ages 18-65
  • All Genders

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 Criteria

Inclusion

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 CSFby a culture or non-culture based microbiologic testing method; 2. Cranial CT or MRIindicating intraventricular floccule or pus.

  • With consent form

Exclusion

Exclusion Criteria:

  • With GCS score of 3

  • With unstable vital signs such as no spontaneous breathing and blood pressuremaintenance drugs

  • With severe propensity for bleeding (Such as coagulation dysfunction, activebleeding, etc.), and unable to tolerate the surgical procedures or operationsrelated to ventricular irrigation treatment.

  • Pregnant or lactating women

Study Design

Total Participants: 310
Treatment Group(s): 1
Primary Treatment: Ventricular irrigation
Phase:
Study Start date:
July 01, 2025
Estimated Completion Date:
December 31, 2028

Study Description

Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Ventriculitis is associated not only with community-acquired diseases but also, more importantly, with invasive clinical procedures, including craniotomy, external ventricular drainage (EVD), lumbar cistern drainage, V-P shunt, and deep brain stimulation, among others. Depending on the diagnostic criteria, the incidence of post-neurosurgery ventriculitis ranges from approximately 5% to 20%, with risk factors including age, prolonged placement of EVD, and intracranial hemorrhage. Besides, the pathogens leading to ventricular infection are also diverse, with the main pathogens including coagulase-negative Staphylococci, Staphylococcus aureus, Propionibacterium acnes, and Gram-negative bacilli.

The treatment for ventriculitis is challenging, with poor prognosis. Under currently widely adopted treatment strategies, 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. This imposes significant burden on families and society. Therefore, how to further improve prognosis of ventriculitis, and reduce the mortality and disability rates, remains to be addressed.

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. As an infectious disease, surgical procedures such as irrigation and drainage have the potential to play a role in reducing infection and improving prognosis for ventriculitis.

In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques (including endoscopic ventricular irrigation and dual catheter irrigation techniques) via replacing saline and draining purulent cerebrospinal fluid (CSF), 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. A prospective controlled study that included 33 patients with ventriculitis divided participants into groups receiving ventricular irrigation treatment and conventional treatment. The study results showed that compared to conventional treatment, ventricular irrigation resulted in higher mRS prognosis scores, shorter hospital stays, and the study also showed a trend towards reduced mortality in irrigation group. However, this study was limited by a small sample size, limited study endpoints and not strictly randomized. Currently, high-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis.

Based on these considerations, 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.

Connect with a study center

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

    Hefei, Anhui
    China

    Site Not Available

  • The Second People's Hospital of Anhui Province

    Hefei, Anhui
    China

    Site Not Available

  • First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui
    China

    Site Not Available

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

    Hefei 1808722, Anhui 1818058
    China

    Site Not Available

  • The Second People's Hospital of Anhui Province

    Hefei 1808722, Anhui 1818058
    China

    Site Not Available

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu 1791236, Anhui 1818058
    China

    Site Not Available

  • Beijing Tiantan Hospital Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • Beijing Tiantan Hospital Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing 1816670, Beijing Municipality 2038349
    China

    Site Not Available

  • Xuanwu Hospital Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349
    China

    Site Not Available

  • The southwest hospital of Army medical university

    Chongqi, Chongqing Municipality 1814905
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou 1810821, Fujian 1811017
    China

    Site Not Available

  • The Second Hospital & Clinical Medical School, Lanzhou University

    Lanzhou, Gansu
    China

    Site Not Available

  • The Second Hospital & Clinical Medical School, Lanzhou University

    Lanzhou 1804430, Gansu 1810676
    China

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • Zhongshan Hospital of Traditional Chinese Medicine

    Zhongshan, Guangdong
    China

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou 1809858, Guangdong 1809935
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou 1809858, Guangdong 1809935
    China

    Site Not Available

  • Shenzhen Second People's Hospital

    Shenzhen 1795565, Guangdong 1809935
    China

    Site Not Available

  • Zhongshan Hospital of Traditional Chinese Medicine

    Zhongshan 6986104, Guangdong 1809935
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Harbin 2037013, Heilongjiang 2036965
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou 1784658, Henan 1808520
    China

    Site Not Available

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

    Wuhan, Hubei
    China

    Site Not Available

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

    Wuhan 1791247, Hubei 1806949
    China

    Active - Recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691
    China

    Site Not Available

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu
    China

    Site Not Available

  • 904 Hospital of the People's Liberation Army Joint Logistic Support Force

    Wuxi, Jiangsu
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu
    China

    Site Not Available

  • Affiliated Hospital of Yangzhou University

    Yangzhou, Jiangsu
    China

    Site Not Available

  • General Hospital of Eastern Theater Command

    Nanjing 1799962, Jiangsu 1806260
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing 1799962, Jiangsu 1806260
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing 1799962, Jiangsu 1806260
    China

    Site Not Available

  • Affiliated Hospital of Nantong University

    Nantong 1799722, Jiangsu 1806260
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou 1886760, Jiangsu 1806260
    China

    Site Not Available

  • 904 Hospital of the People's Liberation Army Joint Logistic Support Force

    Wuxi 1790923, Jiangsu 1806260
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou 10630003, Jiangsu 1806260
    China

    Site Not Available

  • Affiliated Hospital of Yangzhou University

    Yangzhou 1787227, Jiangsu 1806260
    China

    Site Not Available

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi
    China

    Site Not Available

  • Ganzhou People's Hospital

    Ganzhou 1810638, Jiangxi 1806222
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang 1800163, Jiangxi 1806222
    China

    Site Not Available

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang, Liaoning
    China

    Site Not Available

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang 2034937, Liaoning 2036115
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan 1786657, Ningxia 1799355
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia Hui Autonomous Region
    China

    Site Not Available

  • The Second Affiliated Hospital of Air Force Medical University

    Xi'an, Shaanxi
    China

    Site Not Available

  • The Second Affiliated Hospital of Air Force Medical University

    Xi'an 1790630, Shaanxi 1796480
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan 1805753, Shandong 1796328
    China

    Site Not Available

  • Huashan Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Renji Hospital, School of Medicine, Shanghai Jiaotong University

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai Donglei Brain Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai East Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Huashan Hospital

    Shanghai 1796236, Shanghai Municipality 1796231
    China

    Site Not Available

  • Renji Hospital, School of Medicine, Shanghai Jiaotong University

    Shanghai 1796236, Shanghai Municipality 1796231
    China

    Active - Recruiting

  • Shanghai Donglei Brain Hospital

    Shanghai 1796236, Shanghai Municipality 1796231
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai 1796236, Shanghai Municipality 1796231
    China

    Site Not Available

  • Shanghai Tenth People's Hospital

    Shanghai 1796236, Shanghai Municipality 1796231
    China

    Site Not Available

  • The Second Affiliated Hospital of Naval Medical University

    Shanghai 1796236, Shanghai Municipality 1796231
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu 1815286, Sichuan 1794299
    China

    Site Not Available

  • The Affiliated Hospital of Southwest Medical University

    Luzhou 1801640, Sichuan 1794299
    China

    Site Not Available

  • Inner Mongolia People's Hospital

    Hohhot 2036892, The Nei Monggol Autonomous Region
    China

    Site Not Available

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang Uygur Autonomous Region
    China

    Site Not Available

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi 1529102, Xinjiang Uygur Autonomous Region
    China

    Site Not Available

  • First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang
    China

    Site Not Available

  • South taihu hospital affiliated to huzhou college

    Huzhou, Zhejiang
    China

    Site Not Available

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Site Not Available

  • First Affiliated Hospital of Zhejiang University

    Hangzhou 1808926, Zhejiang 1784764
    China

    Site Not Available

  • South taihu hospital affiliated to huzhou college

    Huzhou 1806535, Zhejiang 1784764
    China

    Active - Recruiting

  • The affiliated people's hospital of ningbo university

    Ningbo 1799397, Zhejiang 1784764
    China

    Site Not Available

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou 1791388, Zhejiang 1784764
    China

    Site Not Available

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