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NCT Number: NCT06358209

Safety and Efficacy of Ventricular Irrigation for Ventriculitis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventricular irrigation

Procedure

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.

Primary outcomes

  1. Clinical cure rate

    Time frame: 4 weeks after enrollment

    Clinical cure rate at 4 weeks after enrollment and randomization

Secondary outcomes

  1. GOSE

    Time frame: up 6 months after enrollment and randomization

    Extended Glasgow Outcome Scale at discharge and within 6 months after diagnosis of ventriculitis

  2. Microbial clearance rate

    Time frame: 4 weeks after enrollment

    Microbial clearance rate at 4 weeks after enrollment and randomization

  3. CSF test results

    Time frame: 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

  4. Cranial CT or MRI indicating

    Time frame: 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

  5. Length of ICU stay and hospital stay

    Time frame: up to 6 months after enrollment and randomization

    Length of ICU stay and hospital stay

  6. Complications

    Time frame: up to 6 months after enrollment and randomization

    Blood from puncture canal and intracranial during hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Jiyao Jiang, Dr

CONTACT

[email protected]

021-68383729

Junfeng Feng, Dr

CONTACT

[email protected]

13611860825

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • 904th Hospital of the Joint Logistics Support Force of the PLA
  • Affiliated Hospital of Nantong University
  • First Affiliated Hospital of Fujian Medical University
  • First Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Wannan Medical College
  • First Affiliated Hospital of Xinjiang Medical University
  • First Affiliated Hospital of Zhejiang University
  • Ganzhou City People's Hospital
  • Henan Provincial People's Hospital
  • Inner Mongolia People's Hospital
  • Nanfang Hospital, Southern Medical University
  • Qilu Hospital of Shandong University
  • Second Affiliated Hospital of Nanchang University
  • Shanghai 10th People's Hospital
  • Shanghai Donglei Brain Hospital
  • Shanghai East Hospital
  • Shenzhen Second People's Hospital
  • South Taihu Hospital Affiliated to Huzhou College
  • Southern Medical University, China
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The Affiliated People's Hospital of Ningbo University
  • The First Affiliated Hospital of Soochow University
  • The First Affiliated Hospital of University of Science and Technology of China
  • The First Affiliated Hospital with Nanjing Medical University
  • The Fourth Affiliated Hospital of China Medical University
  • The Second Affiliated Hospital of Air Force Military Medical University
  • The Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital)
  • The Second People's Hospital of Anhui Province
  • Tongji Hospital
  • West China Hospital
  • Xiangya Hospital of Central South University
  • Xuanwu Hospital, Beijing
  • Yangzhou University
  • Zhongshan Hospital Of Traditional Chinese Medicine

Registry information

Official study title

Safety and Efficacy of Ventricular Irrigation for Ventriculitis: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 10, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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