NCT06358209 Safety and Efficacy of Ventricular Irrigation for Ventriculitis
| NCT ID | NCT06358209 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Central Nervous System Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 310 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 310 participants in total. It began in 2025-07-01 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jiyao Jiang, Dr
PRINCIPAL INVESTIGATOR
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Frequently Asked Questions
Who can join the NCT06358209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Central Nervous System Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06358209 currently recruiting?
Yes, NCT06358209 is actively recruiting participants. Contact the research team at jiyaojiang@126.com for enrollment information.
Where is the NCT06358209 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China, Wuhu, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT06358209 clinical trial?
NCT06358209 is sponsored by RenJi Hospital. The principal investigator is Jiyao Jiang, Dr at Renji Hospital, School of Medicine, Shanghai Jiaotong University. The trial plans to enroll 310 participants.