Safety and Efficacy of Ventricular Irrigation for Ventriculitis
- Conditions
- Central Nervous System Infections
- Interventions
- Procedure: Ventricular irrigation
- Registration Number
- NCT06358209
- Lead Sponsor
- RenJi Hospital
- 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 severe ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with severe 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 severe ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with severe ventriculitis.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 310
- Age 18-65 years old;
- CSF is purulent 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
- With GCS score of 3
- With unstable vital signs such as no spontaneous breathing and blood pressure maintenance drugs
- With serious infections in other parts of the body
- With propensity for bleeding, including history of hemophilia, anticoagulant medication, and abnormal coagulation upon admission
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ventricular irrigation group Ventricular irrigation Intervention group employs dual-catheter ventricular irrigation, with the lavage catheter placed in the frontal horn of lateral ventricle, and the drainage catheter placed through another burr hole in the ipsilateral occipital horn or in the contralateral ventricle. Lavage is performed twice daily, with each time 500ml of saline over a duration of one hour. Aside from lavage sessions, the lavage is paused, but continuous CSF drainage remains open. Additional treatments, including the administration of antibiotics, are consistent with those in the control group.
- Primary Outcome Measures
Name Time Method Clinical cure rate 4 weeks after enrollment Clinical cure rate at 4 weeks after enrollment and randomization
- Secondary Outcome Measures
Name Time Method GOSE At discharge and within 6 months after diagnosis Extended Glasgow Outcome Scale at discharge and within 6 months after diagnosis of ventriculitis
CSF test results At 8th day after enrollment, and within 1 week before discharge 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
Cranial CT or MRI indicating At 8th day after enrollment, and within 1 week before discharge Cranial CT or MRI indicating at 8th day after enrollment, and within 1 week before discharge
The maximum body temperature of each day From enrollment to discharge The maximum body temperature of each day from enrollment to discharge
Length of stay After diagnosis Length of hospital stay
Complications During hospitalization Blood from puncture canal and intracranial during hospitalization
Trial Locations
- Locations (7)
First Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
904 Hospital of the People's Liberation Army Joint Logistic Support Force
🇨🇳Wuxi, Jiangsu, China
Huashan Hospital
🇨🇳Shanghai, Shanghai, China
Renji Hospital, School of Medicine, Shanghai Jiaotong University
🇨🇳Shanghai, Shanghai, China
First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China