Safety and Efficacy of Ventricular Irrigation for Ventriculitis

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.

Conditions

• Central Nervous System Infections

Interventions

PROCEDURE

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.

Sponsors & Collaborators

• Southern Medical University, China

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

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

  collaborator OTHER

• Shenzhen Second People's Hospital

  collaborator OTHER

• Shanghai East Hospital

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• South Taihu Hospital Affiliated to Huzhou College

  collaborator UNKNOWN

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Yangzhou University

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• Zhongshan Hospital Of Traditional Chinese Medicine

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Air Force Medical University

  collaborator UNKNOWN

• Qilu Hospital of Shandong University

  collaborator OTHER

• The Fourth Affiliated Hospital of China Medical University

  collaborator OTHER

• Ganzhou People's Hospital

  collaborator UNKNOWN

• Xiangya Hospital of Central South University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• The Second People's Hospital of Anhui Province

  collaborator OTHER

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

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Shanghai Donglei Brain Hospital

  collaborator UNKNOWN

• The Affiliated People's Hospital of Ningbo University

  collaborator OTHER_GOV

• Inner Mongolia People's Hospital

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• The First Affiliated Hospital of Wannan Medical College（Yijishan Hospital of Wannan Medical College）

  collaborator UNKNOWN

• The Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital)

  collaborator UNKNOWN

• Shanghai 10th People's Hospital

  collaborator OTHER

• RenJi Hospital

  lead OTHER

Principal Investigators

• Jiyao Jiang, Dr · Renji Hospital, School of Medicine, Shanghai Jiaotong University

• Junfeng Feng, Dr · Renji Hospital, School of Medicine, Shanghai Jiaotong University

• Qinghua Wang, Dr · Southern Medical University, China

• Xiaofeng Yang, Dr · First Affiliated Hospital of Zhejiang University

• Yuhai Wang, Dr · 904th Hospital of the Joint Logistics Support Force of the PLA

• Xianjian Huang, Dr · Shenzhen Second People's Hospital

• Xuefei Shao, Dr · First Affiliated Hospital of Wannan Medical College

• Lijun Hou, Dr · The Second Affiliated Hospital of Naval Medical University

• Chunlong Zhong, Dr · Shanghai East Hospital

• Liang Gao, Dr · Shanghai Donglei Brain Hospital

• Rongcai Jiang, Dr · Xuanwu Hospital, Beijing

• Liansheng Long, Dr · South Taihu Hospital Affiliated to Huzhou College

• Feng Gao, Dr · he affiliated people's hospital of ningbo university

• Chunhua Hang, Dr · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

• Jing Ji, Dr · The First Affiliated Hospital with Nanjing Medical University

• Xiaoou Sun, Dr · The First Affiliated Hospital of Soochow University

• Aijun Peng, Dr · Yangzhou University

• Jinlong Shi, Dr · Affiliated Hospital of Nantong University

• Binghui Qiu, Dr · Nanfang Hospital, Southern Medical University

• Dan Jin, Dr · Zhongshan Hospital Of Traditional Chinese Medicine

• Yongxin Wang, Dr · First Affiliated Hospital of Xinjiang Medical University

• Chaohua Yang, Dr · West China Hospital

• Qibing Huang, Dr · Qilu Hospital of Shandong University

• Yan Qu, Dr · The Second Affiliated Hospital of Air Force Medical University

• Yan Zhang, Dr · Second Affiliated Hospital of Nanchang University

• Qiuhua Jiang, Dr · Ganzhou People's Hospital

• Yijun Bao, Dr · The Fourth Affiliated Hospital of China Medical University

• Hongsheng Liang, Dr · First Affiliated Hospital of Harbin Medical University

• Wenhua Fang, Dr · First Affiliated Hospital of Fujian Medical University

• Guang Feng, Dr · Henan Provincial People's Hospital

• Kai Shu, Dr · Tongji Hospital

• Jinfang Liu, Dr · Xiangya Hospital of Central South University

• Weiping Zhao, Dr · Inner Mongolia People's Hospital

• Yongming Zhang, Dr · The Second People's Hospital of Anhui Province

• Xiangpin Wei, Dr · The First Affiliated Hospital of University of Science and Technology of China

• Xianzhen Chen, Dr · Shanghai 10th People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2028-06-30

Completion

2028-12-31

Countries

• China

Study Locations