Safety and Efficacy of Ventricular Irrigation for Ventriculitis
NCT ID: NCT06358209
Last Updated: 2026-01-02
Study Results
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Basic Information
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RECRUITING
NA
310 participants
INTERVENTIONAL
2025-07-01
2028-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
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)".
No interventions assigned to this group
Ventricular irrigation group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Southern Medical University, China
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
904th Hospital of the Joint Logistics Support Force of the PLA
OTHER
Shenzhen Second People's Hospital
OTHER
Shanghai East Hospital
OTHER
Xuanwu Hospital, Beijing
OTHER
South Taihu Hospital Affiliated to Huzhou College
UNKNOWN
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Yangzhou University
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Zhongshan Hospital Of Traditional Chinese Medicine
OTHER
Nanfang Hospital, Southern Medical University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
West China Hospital
OTHER
The Second Affiliated Hospital of Air Force Medical University
UNKNOWN
Qilu Hospital of Shandong University
OTHER
The Fourth Affiliated Hospital of China Medical University
OTHER
Ganzhou People's Hospital
UNKNOWN
Xiangya Hospital of Central South University
OTHER
Tongji Hospital
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Henan Provincial People's Hospital
OTHER
The Second People's Hospital of Anhui Province
OTHER
The First Affiliated Hospital of University of Science and Technology of China
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
Shanghai Donglei Brain Hospital
UNKNOWN
The Affiliated People's Hospital of Ningbo University
OTHER_GOV
Inner Mongolia People's Hospital
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
Affiliated Hospital of Nantong University
OTHER
The First Affiliated Hospital of Wannan Medical College（Yijishan Hospital of Wannan Medical College）
UNKNOWN
The Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital)
UNKNOWN
Shanghai 10th People's Hospital
OTHER
RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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Jiyao Jiang, Dr
Role: PRINCIPAL_INVESTIGATOR
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Junfeng Feng, Dr
Role: STUDY_DIRECTOR
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Qinghua Wang, Dr
Role: STUDY_DIRECTOR
Southern Medical University, China
Xiaofeng Yang, Dr
Role: STUDY_DIRECTOR
First Affiliated Hospital of Zhejiang University
Yuhai Wang, Dr
Role: STUDY_DIRECTOR
904th Hospital of the Joint Logistics Support Force of the PLA
Xianjian Huang, Dr
Role: STUDY_DIRECTOR
Shenzhen Second People's Hospital
Xuefei Shao, Dr
Role: STUDY_DIRECTOR
First Affiliated Hospital of Wannan Medical College
Lijun Hou, Dr
Role: STUDY_DIRECTOR
The Second Affiliated Hospital of Naval Medical University
Chunlong Zhong, Dr
Role: STUDY_DIRECTOR
Shanghai East Hospital
Liang Gao, Dr
Role: STUDY_DIRECTOR
Shanghai Donglei Brain Hospital
Rongcai Jiang, Dr
Role: STUDY_DIRECTOR
Xuanwu Hospital, Beijing
Liansheng Long, Dr
Role: STUDY_DIRECTOR
South Taihu Hospital Affiliated to Huzhou College
Feng Gao, Dr
Role: STUDY_DIRECTOR
he affiliated people's hospital of ningbo university
Chunhua Hang, Dr
Role: STUDY_DIRECTOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Jing Ji, Dr
Role: STUDY_DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Xiaoou Sun, Dr
Role: STUDY_DIRECTOR
The First Affiliated Hospital of Soochow University
Aijun Peng, Dr
Role: STUDY_DIRECTOR
Yangzhou University
Jinlong Shi, Dr
Role: STUDY_DIRECTOR
Affiliated Hospital of Nantong University
Binghui Qiu, Dr
Role: STUDY_DIRECTOR
Nanfang Hospital, Southern Medical University
Dan Jin, Dr
Role: STUDY_DIRECTOR
Zhongshan Hospital Of Traditional Chinese Medicine
Yongxin Wang, Dr
Role: STUDY_DIRECTOR
First Affiliated Hospital of Xinjiang Medical University
Chaohua Yang, Dr
Role: STUDY_DIRECTOR
West China Hospital
Qibing Huang, Dr
Role: STUDY_DIRECTOR
Qilu Hospital of Shandong University
Yan Qu, Dr
Role: STUDY_DIRECTOR
The Second Affiliated Hospital of Air Force Medical University
Yan Zhang, Dr
Role: STUDY_DIRECTOR
Second Affiliated Hospital of Nanchang University
Qiuhua Jiang, Dr
Role: STUDY_DIRECTOR
Ganzhou People's Hospital
Yijun Bao, Dr
Role: STUDY_DIRECTOR
The Fourth Affiliated Hospital of China Medical University
Hongsheng Liang, Dr
Role: STUDY_DIRECTOR
First Affiliated Hospital of Harbin Medical University
Wenhua Fang, Dr
Role: STUDY_DIRECTOR
First Affiliated Hospital of Fujian Medical University
Guang Feng, Dr
Role: STUDY_DIRECTOR
Henan Provincial People's Hospital
Kai Shu, Dr
Role: STUDY_DIRECTOR
Tongji Hospital
Jinfang Liu, Dr
Role: STUDY_DIRECTOR
Xiangya Hospital of Central South University
Weiping Zhao, Dr
Role: STUDY_DIRECTOR
Inner Mongolia People's Hospital
Yongming Zhang, Dr
Role: STUDY_DIRECTOR
The Second People's Hospital of Anhui Province
Xiangpin Wei, Dr
Role: STUDY_DIRECTOR
The First Affiliated Hospital of University of Science and Technology of China
Xianzhen Chen, Dr
Role: STUDY_DIRECTOR
Shanghai 10th People's Hospital
Locations
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The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
The Second People's Hospital of Anhui Province
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
904 Hospital of the People's Liberation Army Joint Logistic Support Force
Wuxi, Jiangsu, China
Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Shanghai Donglei Brain Hospital
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Inner Mongolia People's Hospital
Hohhot, The Nei Monggol Autonomous Region, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, China
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
South taihu hospital affiliated to huzhou college
Huzhou, Zhejiang, China
The affiliated people's hospital of ningbo university
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xiangpin Wei, Dr
Role: primary
Yongming Zhang, Dr
Role: primary
Xuefei Shao, Dr
Role: primary
Rongcai Jiang, Dr
Role: primary
Wenhua Fang, Dr
Role: primary
Binghui Qiu, Dr
Role: primary
Qinghua Wang, Dr
Role: primary
Xianjian Huang, Dr
Role: primary
Dan Jin, Dr
Role: primary
Hongsheng Liang, Dr
Role: primary
Guang Feng, Dr
Role: primary
Kai Shu, Dr
Role: primary
Jinfang Liu, Dr
Role: primary
Jing Ji, Dr
Role: primary
Chunhua Hang, Dr
Role: primary
Jinlong Shi, Dr
Role: primary
Xiaoou Sun, Dr
Role: primary
Yuhai Wang, Dr
Role: primary
Aijun Peng, Dr
Role: primary
Qiuhua Jiang, Dr
Role: primary
Yan Zhang, Dr
Role: primary
Yijun Bao, Dr
Role: primary
Yan Qu, Dr
Role: primary
Qibing Huang, Dr
Role: primary
Liang Gao, Dr
Role: primary
Chunlong Zhong, Dr
Role: primary
Xianzhen Chen, Dr
Role: primary
Lijun Hou, Dr
Role: primary
Chaohua Yang, Dr
Role: primary
Weiping Zhao, Dr
Role: primary
Yongxin Wang, Dr
Role: primary
Xiaofeng Yang, Dr
Role: primary
Liansheng Long, Dr
Role: primary
Feng Gao, Dr
Role: primary
References
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Tunkel AR, Hasbun R, Bhimraj A, Byers K, Kaplan SL, Scheld WM, van de Beek D, Bleck TP, Garton HJL, Zunt JR. 2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis. Clin Infect Dis. 2017 Mar 15;64(6):e34-e65. doi: 10.1093/cid/ciw861.
Al Menabbawy A, El Refaee E, Soliman MAR, Elborady MA, Katri MA, Fleck S, Schroeder HWS, Zohdi A. Outcome improvement in cerebral ventriculitis after ventricular irrigation: a prospective controlled study. J Neurosurg Pediatr. 2020 Sep 4;26(6):682-690. doi: 10.3171/2020.5.PEDS2063. Print 2020 Dec 1.
Hasbun R. Healthcare-associated ventriculitis: current and emerging diagnostic and treatment strategies. Expert Rev Anti Infect Ther. 2021 Aug;19(8):993-999. doi: 10.1080/14787210.2021.1866544. Epub 2020 Dec 24.
Humphreys H, Jenks PJ. Surveillance and management of ventriculitis following neurosurgery. J Hosp Infect. 2015 Apr;89(4):281-6. doi: 10.1016/j.jhin.2014.12.019. Epub 2015 Jan 29.
Rogers T, Sok K, Erickson T, Aguilera E, Wootton SH, Murray KO, Hasbun R. Impact of Antibiotic Therapy in the Microbiological Yield of Healthcare-Associated Ventriculitis and Meningitis. Open Forum Infect Dis. 2019 Feb 6;6(3):ofz050. doi: 10.1093/ofid/ofz050. eCollection 2019 Mar.
Karvouniaris M, Brotis A, Tsiakos K, Palli E, Koulenti D. Current Perspectives on the Diagnosis and Management of Healthcare-Associated Ventriculitis and Meningitis. Infect Drug Resist. 2022 Feb 28;15:697-721. doi: 10.2147/IDR.S326456. eCollection 2022.
Karvouniaris M, Brotis AG, Tsiamalou P, Fountas KN. The Role of Intraventricular Antibiotics in the Treatment of Nosocomial Ventriculitis/Meningitis from Gram-Negative Pathogens: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Dec;120:e637-e650. doi: 10.1016/j.wneu.2018.08.138. Epub 2018 Aug 29.
Luque-Paz D, Revest M, Eugene F, Boukthir S, Dejoies L, Tattevin P, Le Reste PJ. Ventriculitis: A Severe Complication of Central Nervous System Infections. Open Forum Infect Dis. 2021 Apr 29;8(6):ofab216. doi: 10.1093/ofid/ofab216. eCollection 2021 Jun.
Chan AK, Birk HS, Yue JK, Winkler EA, McDermott MW. Bilateral External Ventricular Drain Placement and Intraventricular Irrigation Combined with Concomitant Serial Prone Patient Positioning: A Novel Treatment for Gravity-Dependent Layering in Bacterial Ventriculitis. Cureus. 2017 Apr 18;9(4):e1175. doi: 10.7759/cureus.1175.
Terada Y, Mineharu Y, Arakawa Y, Funaki T, Tanji M, Miyamoto S. Effectiveness of neuroendoscopic ventricular irrigation for ventriculitis. Clin Neurol Neurosurg. 2016 Jul;146:147-51. doi: 10.1016/j.clineuro.2016.05.010. Epub 2016 May 9.
Gaderer C, Schaumann A, Schulz M, Thomale UW. Neuroendoscopic lavage for the treatment of CSF infection with hydrocephalus in children. Childs Nerv Syst. 2018 Oct;34(10):1893-1903. doi: 10.1007/s00381-018-3894-7. Epub 2018 Jul 11.
Qin G, Liang Y, Xu K, Xu P, Ye J, Tang X, Lan S. Neuroendoscopic lavage for ventriculitis: Case report and literature review. Neurochirurgie. 2020 Apr;66(2):127-132. doi: 10.1016/j.neuchi.2019.12.005. Epub 2020 Feb 19.
Stati G, Migliorino E, Moneti M, Castioni CA, Scibilia A, Palandri G, Virgili G, Aspide R. Treatment of cerebral ventriculitis with a new self-irrigating catheter system: narrative review and case series. J Anesth Analg Crit Care. 2023 Nov 8;3(1):46. doi: 10.1186/s44158-023-00131-5.
de Sousa Carvalho Dezena JE, Gerbelli CLB, Braga TKK, Ballestero MFM. How I do it: brainwashing for purulent ventriculitis. Acta Neurochir (Wien). 2023 Nov;165(11):3267-3269. doi: 10.1007/s00701-023-05607-5. Epub 2023 May 20.
Tomita Y, Shimazu Y, Kawakami M, Matsumoto H, Fujii K, Kameda M, Yasuhara T, Suruga Y, Ota T, Kimata Y, Kurozumi K, Date I. Pyogenic Ventriculitis After Anterior Skull Base Surgery Treated With Endoscopic Ventricular Irrigation And Reconstruction Using a Vascularized Flap. Acta Med Okayama. 2021 Apr;75(2):243-248. doi: 10.18926/AMO/61908.
Ochoa A, Arganaraz R, Mantese B. Neuroendoscopic lavage for the treatment of pyogenic ventriculitis in children: personal series and review of the literature. Childs Nerv Syst. 2022 Mar;38(3):597-604. doi: 10.1007/s00381-021-05413-3. Epub 2021 Nov 13.
Other Identifiers
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LY2024-045-B
Identifier Type: -
Identifier Source: org_study_id
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