Safety and Efficacy of Ventricular Irrigation for Ventriculitis
ConditionCentral Nervous System Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRenJi Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ventricular irrigation
Procedure/SurgeryCatheter 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.
Treatment groups
310 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Ventricular irrigation groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical cure rate
Clinical cure rate at 4 weeks after enrollment and randomization
Time frame
4 weeks after enrollmentSecondary outcomes
1
GOSE
Extended Glasgow Outcome Scale at discharge and within 6 months after diagnosis of ventriculitis
Time frame
up 6 months after enrollment and randomization2
Microbial clearance rate
Microbial clearance rate at 4 weeks after enrollment and randomization
Time frame
4 weeks after enrollment3
CSF test results
Results 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
Time frame
At 8th day after enrollment, and within 1 week before discharge4
Cranial CT or MRI indicating
Cranial CT or MRI indicating at 8th day after enrollment, and within 1 week before discharge
Time frame
At 8th day after enrollment, and within 1 week before dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
RenJi Hospital
Lead sponsor
Southern Medical University, China
Collaborator
First Affiliated Hospital of Zhejiang University
Collaborator
904th Hospital of the Joint Logistics Support Force of the PLA
Collaborator
Shenzhen Second People's Hospital
Collaborator
Shanghai East Hospital
Collaborator
Xuanwu Hospital, Beijing
Collaborator
South Taihu Hospital Affiliated to Huzhou College
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Yangzhou University
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator
Zhongshan Hospital Of Traditional Chinese Medicine
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
West China Hospital
Collaborator
The Second Affiliated Hospital of Air Force Military Medical University
Collaborator
Qilu Hospital of Shandong University
Collaborator
The Fourth Affiliated Hospital of China Medical University
Collaborator
Ganzhou City People's Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Tongji Hospital
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
Henan Provincial People's Hospital
Collaborator
The Second People's Hospital of Anhui Province
Collaborator
The First Affiliated Hospital of University of Science and Technology of China
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
Shanghai Donglei Brain Hospital
Collaborator
The Affiliated People's Hospital of Ningbo University
Collaborator
Inner Mongolia People's Hospital
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
Affiliated Hospital of Nantong University
Collaborator
First Affiliated Hospital of Wannan Medical College
Collaborator
The Second Affiliated Hospital of Naval Medical University
Collaborator
Shanghai 10th People's Hospital
Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborator
The First People's Hospital of Zhangjiagang City
Collaborator
Suzhou Municipal Hospital
Collaborator
Liaocheng People's Hospital
Collaborator
Jining First People's Hospital
Collaborator
Qilu Hospital of Shandong University (Qingdao)
Collaborator
Weifang People's Hospital（The First Affiliated Hospital of Shandong Second Medical University）
Collaborator
Dezhou Hospital Qilu Hospital of Shandong University
Collaborator
Second Affiliated Hospital of Wenzhou Medical University
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
Hainan General Hospital
Collaborator
Southwest Hospital （The First Hospital Affiliated to AMU）
Collaborator
The Peoples' Hospital of Jiaozuo City
Collaborator
Kaifeng Central Hospital, Henan Province, P.R. China
Collaborator
Zhumadian Center Hospital
Collaborator
Zhoukou Central Hospital
Collaborator
Zhengzhou Center Hospital Affiliated to Zhengzhou University
Collaborator
Anyang People's Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
The Third Affiliated Hospital of Henan Medical University
Collaborator
Nanyang Central Hosptial
Collaborator
Xuchang Central Hospital
Collaborator
Sanmenxia Central Hospital
Collaborator
The Second Hospital & Clinical Medical School, Lanzhou University
Collaborator
General Hospital of Ningxia Medical University
Collaborator
Source ClinicalTrials.gov