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Safety and Efficacy of Ventricular Irrigation for Ventriculitis

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06358209
Enrollment
310
Registered
2024-04-10
Start date
2025-07-01
Completion date
2028-12-31
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Infections

Keywords

Ventriculitis, Ventricular irrigation

Brief 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.

Detailed 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.

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.

Sponsors

RenJi Hospital
Lead SponsorOTHER
Southern Medical University, China
CollaboratorOTHER
First Affiliated Hospital of Zhejiang University
CollaboratorOTHER
904th Hospital of the Joint Logistics Support Force of the PLA
CollaboratorOTHER
Shenzhen Second People's Hospital
CollaboratorOTHER
Shanghai East Hospital
CollaboratorOTHER
Xuanwu Hospital, Beijing
CollaboratorOTHER
South Taihu Hospital Affiliated to Huzhou College
CollaboratorUNKNOWN
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
CollaboratorOTHER
The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
Yangzhou University
CollaboratorOTHER
The First Affiliated Hospital of Soochow University
CollaboratorOTHER
Zhongshan Hospital Of Traditional Chinese Medicine
CollaboratorOTHER
Nanfang Hospital, Southern Medical University
CollaboratorOTHER
First Affiliated Hospital of Xinjiang Medical University
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
The Second Affiliated Hospital of Air Force Military Medical University
CollaboratorOTHER
Qilu Hospital of Shandong University
CollaboratorOTHER
The Fourth Affiliated Hospital of China Medical University
CollaboratorOTHER
Ganzhou City People's Hospital
CollaboratorOTHER
Xiangya Hospital of Central South University
CollaboratorOTHER
Tongji Hospital
CollaboratorOTHER
First Affiliated Hospital of Harbin Medical University
CollaboratorOTHER
Henan Provincial People's Hospital
CollaboratorOTHER
The Second People's Hospital of Anhui Province
CollaboratorOTHER
The First Affiliated Hospital of University of Science and Technology of China
CollaboratorOTHER
First Affiliated Hospital of Fujian Medical University
CollaboratorOTHER
Shanghai Donglei Brain Hospital
CollaboratorUNKNOWN
The Affiliated People's Hospital of Ningbo University
CollaboratorOTHER_GOV
Inner Mongolia People's Hospital
CollaboratorOTHER
Second Affiliated Hospital of Nanchang University
CollaboratorOTHER
Affiliated Hospital of Nantong University
CollaboratorOTHER
First Affiliated Hospital of Wannan Medical College
CollaboratorOTHER
The Second Affiliated Hospital of Naval Medical University
CollaboratorUNKNOWN
Shanghai 10th People's Hospital
CollaboratorOTHER
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
CollaboratorOTHER
The First People's Hospital of Zhangjiagang City
CollaboratorUNKNOWN
Suzhou Municipal Hospital
CollaboratorOTHER
Liaocheng People's Hospital
CollaboratorOTHER
Jining First People's Hospital
CollaboratorOTHER
Qilu Hospital of Shandong University (Qingdao)
CollaboratorOTHER
Weifang People's Hospital(The First Affiliated Hospital of Shandong Second Medical University)
CollaboratorUNKNOWN
Dezhou Hospital Qilu Hospital of Shandong University
CollaboratorOTHER
Second Affiliated Hospital of Wenzhou Medical University
CollaboratorOTHER
The Affiliated Hospital of Xuzhou Medical University
CollaboratorOTHER
Hainan General Hospital
CollaboratorOTHER
Southwest Hospital (The First Hospital Affiliated to AMU)
CollaboratorUNKNOWN
The Peoples' Hospital of Jiaozuo City
CollaboratorOTHER
Kaifeng Central Hospital, Henan Province, P.R. China
CollaboratorUNKNOWN
Zhumadian Center Hospital
CollaboratorUNKNOWN
Zhoukou Central Hospital
CollaboratorOTHER
Zhengzhou Center Hospital Affiliated to Zhengzhou University
CollaboratorUNKNOWN
Anyang People's Hospital
CollaboratorUNKNOWN
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
The Third Affiliated Hospital of Henan Medical University
CollaboratorUNKNOWN
Nanyang Central Hosptial
CollaboratorUNKNOWN
Xuchang Central Hospital
CollaboratorOTHER
Sanmenxia Central Hospital
CollaboratorOTHER
The Second Hospital & Clinical Medical School, Lanzhou University
CollaboratorUNKNOWN
General Hospital of Ningxia Medical University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
Clinical cure rate4 weeks after enrollmentClinical cure rate at 4 weeks after enrollment and randomization

Secondary

MeasureTime frameDescription
GOSEup 6 months after enrollment and randomizationExtended Glasgow Outcome Scale at discharge and within 6 months after diagnosis of ventriculitis
Microbial clearance rate4 weeks after enrollmentMicrobial clearance rate at 4 weeks after enrollment and randomization
CSF test resultsAt 8th day after enrollment, and within 1 week before dischargeResults of CSF test at 8th day after enrollment, and within 1 week before discharge, including CSF glucose, CSF protein, CSF WBC count and organism(s) identification by a culture or non-culture based microbiologic testing method
Cranial CT or MRI indicatingAt 8th day after enrollment, and within 1 week before dischargeCranial CT or MRI indicating at 8th day after enrollment, and within 1 week before discharge
Length of ICU stay and hospital stayup to 6 months after enrollment and randomizationLength of ICU stay and hospital stay
Complicationsup to 6 months after enrollment and randomizationBlood from puncture canal and intracranial during hospitalization

Countries

China

Contacts

CONTACTJiyao Jiang, Dr
jiyaojiang@126.com021-68383729
CONTACTJunfeng Feng, Dr
fengjfmail@163.com13611860825
PRINCIPAL_INVESTIGATORJiyao Jiang, Dr

Renji Hospital, School of Medicine, Shanghai Jiaotong University

STUDY_DIRECTORJunfeng Feng, Dr

Renji Hospital, School of Medicine, Shanghai Jiaotong University

STUDY_DIRECTORQinghua Wang, Dr

Southern Medical University, China

STUDY_DIRECTORXiaofeng Yang, Dr

First Affiliated Hospital of Zhejiang University

STUDY_DIRECTORYuhai Wang, Dr

904th Hospital of the Joint Logistics Support Force of the PLA

STUDY_DIRECTORXianjian Huang, Dr

Shenzhen Second People's Hospital

STUDY_DIRECTORXuefei Shao, Dr

First Affiliated Hospital of Wannan Medical College

STUDY_DIRECTORLijun Hou, Dr

The Second Affiliated Hospital of Naval Medical University

STUDY_DIRECTORChunlong Zhong, Dr

Shanghai East Hospital

STUDY_DIRECTORLiang Gao, Dr

Shanghai Donglei Brain Hospital

STUDY_DIRECTORRongcai Jiang, Dr

Xuanwu Hospital, Beijing

STUDY_DIRECTORLiansheng Long, Dr

South Taihu Hospital Affiliated to Huzhou College

STUDY_DIRECTORFeng Gao, Dr

he affiliated people's hospital of ningbo university

STUDY_DIRECTORChunhua Hang, Dr

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

STUDY_DIRECTORJing Ji, Dr

The First Affiliated Hospital with Nanjing Medical University

STUDY_DIRECTORXiaoou Sun, Dr

The First Affiliated Hospital of Soochow University

STUDY_DIRECTORAijun Peng, Dr

Yangzhou University

STUDY_DIRECTORJinlong Shi, Dr

Affiliated Hospital of Nantong University

STUDY_DIRECTORBinghui Qiu, Dr

Nanfang Hospital, Southern Medical University

STUDY_DIRECTORDan Jin, Dr

Zhongshan Hospital Of Traditional Chinese Medicine

STUDY_DIRECTORYongxin Wang, Dr

First Affiliated Hospital of Xinjiang Medical University

STUDY_DIRECTORChaohua Yang, Dr

West China Hospital

STUDY_DIRECTORQibing Huang, Dr

Qilu Hospital of Shandong University

STUDY_DIRECTORYan Qu, Dr

The Second Affiliated Hospital of Air Force Military Medical University

STUDY_DIRECTORYan Zhang, Dr

Second Affiliated Hospital of Nanchang University

STUDY_DIRECTORQiuhua Jiang, Dr

Ganzhou City People's Hospital

STUDY_DIRECTORYijun Bao, Dr

The Fourth Affiliated Hospital of China Medical University

STUDY_DIRECTORHongsheng Liang, Dr

First Affiliated Hospital of Harbin Medical University

STUDY_DIRECTORWenhua Fang, Dr

First Affiliated Hospital of Fujian Medical University

STUDY_DIRECTORGuang Feng, Dr

Henan Provincial People's Hospital

STUDY_DIRECTORKai Shu, Dr

Tongji Hospital

STUDY_DIRECTORJinfang Liu, Dr

Xiangya Hospital of Central South University

STUDY_DIRECTORWeiping Zhao, Dr

Inner Mongolia People's Hospital

STUDY_DIRECTORYongming Zhang, Dr

The Second People's Hospital of Anhui Province

STUDY_DIRECTORXiangpin Wei, Dr

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

STUDY_DIRECTORXianzhen Chen, Dr

Shanghai 10th People's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026