An interventional study of Ventricular irrigation in Central Nervous System Infections, sponsored by RenJi Hospital. Recruiting at 35 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment
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.
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.
41 studies on the registry are indexed under Central Nervous System Infections; 9 are open to participants now.
This study's planned enrollment of 310 is above the median of 108 across 16 interventional studies indexed under Central Nervous System Infections.
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Exclusion Criteria:
Conventional treatments for ventriculitis, including: external ventricular drainage or lumbar cistern drainage for continuous drainage, systemic and intrathecal antibiotics along with other supportive care. The treatment plan, including the type, dosage, and duration of antibiotics, follows guidelines "2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis" and "Chinese Expert Consensus on Diagnosis and Treatment of Central Nervous System Infections in Neurosurgery (2021 Edition)".
Intervention group employs catheter ventricular irrigation with various forms. Lavage is performed with each time at least 200ml of normal saline, and irrigation treatment over 7 days. Additional treatments, including the administration of antibiotics, are consistent with those in the control group.
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.
Clinical cure rate
Clinical cure rate at 4 weeks after enrollment and randomization
Time frame: 4 weeks after enrollment
GOSE
Extended Glasgow Outcome Scale at discharge and within 6 months after diagnosis of ventriculitis
Time frame: up 6 months after enrollment and randomization
Microbial clearance rate
Microbial clearance rate at 4 weeks after enrollment and randomization
Time frame: 4 weeks after enrollment
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 discharge
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 discharge
Length of ICU stay and hospital stay
Length of ICU stay and hospital stay
Time frame: up to 6 months after enrollment and randomization
Complications
Blood from puncture canal and intracranial during hospitalization
Time frame: up to 6 months after enrollment and randomization
Plan to share: Yes — Researchers who submit a methodologically sound study proposal that is approved by the management committee can have access to the study protocol, individual participant data and data dictionary. A Data Access Agreement is required, and all access must comply with regulatory restrictions imposed on the original study.
Supporting information: Study protocol
Time frame: After Publication
Access criteria: Researchers who submit a methodologically sound study proposal that is approved by the management committee can have access to the study protocol, individual participant data and data dictionary.
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