Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Southern Medical University, China | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
| 904th Hospital of the Joint Logistics Support Force of the PLA | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | 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)". | |
| Ventricular irrigation group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate | Clinical cure rate at 4 weeks after enrollment and randomization | 4 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| GOSE | Extended Glasgow Outcome Scale at discharge and within 6 months after diagnosis of ventriculitis | up 6 months after enrollment and randomization |
| Microbial clearance rate | Microbial clearance rate at 4 weeks after enrollment and randomization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiyao Jiang, Dr | Contact | 021-68383729 | jiyaojiang@126.com | |
| Junfeng Feng, Dr | Contact | 13611860825 | fengjfmail@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiyao Jiang, Dr | Renji Hospital, School of Medicine, Shanghai Jiaotong University | Principal Investigator |
| Junfeng Feng, Dr | Renji Hospital, School of Medicine, Shanghai Jiaotong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Not yet recruiting | Hefei | Anhui | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28203777 | Background | 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. | |
| 32886918 | Background |
Not provided
Not provided
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.
After Publication
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.
Not provided
Not provided
| 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 Military Medical University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| The Fourth Affiliated Hospital of China Medical University | OTHER |
| Ganzhou City People's Hospital | OTHER |
| 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 |
| First Affiliated Hospital of Wannan Medical College | OTHER |
| The Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital) | UNKNOWN |
| Shanghai 10th People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
| 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 | 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 | 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 | up to 6 months after enrollment and randomization |
| Complications | Blood from puncture canal and intracranial during hospitalization | up to 6 months after enrollment and randomization |
| Qinghua Wang, Dr | Southern Medical University, China | Study Director |
| Xiaofeng Yang, Dr | First Affiliated Hospital of Zhejiang University | Study Director |
| Yuhai Wang, Dr | 904th Hospital of the Joint Logistics Support Force of the PLA | Study Director |
| Xianjian Huang, Dr | Shenzhen Second People's Hospital | Study Director |
| Xuefei Shao, Dr | First Affiliated Hospital of Wannan Medical College | Study Director |
| Lijun Hou, Dr | The Second Affiliated Hospital of Naval Medical University | Study Director |
| Chunlong Zhong, Dr | Shanghai East Hospital | Study Director |
| Liang Gao, Dr | Shanghai Donglei Brain Hospital | Study Director |
| Rongcai Jiang, Dr | Xuanwu Hospital, Beijing | Study Director |
| Liansheng Long, Dr | South Taihu Hospital Affiliated to Huzhou College | Study Director |
| Feng Gao, Dr | he affiliated people's hospital of ningbo university | Study Director |
| Chunhua Hang, Dr | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Study Director |
| Jing Ji, Dr | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Xiaoou Sun, Dr | The First Affiliated Hospital of Soochow University | Study Director |
| Aijun Peng, Dr | Yangzhou University | Study Director |
| Jinlong Shi, Dr | Affiliated Hospital of Nantong University | Study Director |
| Binghui Qiu, Dr | Nanfang Hospital, Southern Medical University | Study Director |
| Dan Jin, Dr | Zhongshan Hospital Of Traditional Chinese Medicine | Study Director |
| Yongxin Wang, Dr | First Affiliated Hospital of Xinjiang Medical University | Study Director |
| Chaohua Yang, Dr | West China Hospital | Study Director |
| Qibing Huang, Dr | Qilu Hospital of Shandong University | Study Director |
| Yan Qu, Dr | The Second Affiliated Hospital of Air Force Military Medical University | Study Director |
| Yan Zhang, Dr | Second Affiliated Hospital of Nanchang University | Study Director |
| Qiuhua Jiang, Dr | Ganzhou City People's Hospital | Study Director |
| Yijun Bao, Dr | The Fourth Affiliated Hospital of China Medical University | Study Director |
| Hongsheng Liang, Dr | First Affiliated Hospital of Harbin Medical University | Study Director |
| Wenhua Fang, Dr | First Affiliated Hospital of Fujian Medical University | Study Director |
| Guang Feng, Dr | Henan Provincial People's Hospital | Study Director |
| Kai Shu, Dr | Tongji Hospital | Study Director |
| Jinfang Liu, Dr | Xiangya Hospital of Central South University | Study Director |
| Weiping Zhao, Dr | Inner Mongolia People's Hospital | Study Director |
| Yongming Zhang, Dr | The Second People's Hospital of Anhui Province | Study Director |
| Xiangpin Wei, Dr | The First Affiliated Hospital of University of Science and Technology of China | Study Director |
| Xianzhen Chen, Dr | Shanghai 10th People's Hospital | Study Director |
| The Second People's Hospital of Anhui Province | Not yet recruiting | Hefei | Anhui | China |
|
| The First Affiliated Hospital of Wannan Medical College | Not yet recruiting | Wuhu | Anhui | China |
|
| Xuanwu Hospital Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| The First Affiliated Hospital of Fujian Medical University | Not yet recruiting | Fuzhou | Fujian | China |
|
| Nanfang Hospital, Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
|
| Zhujiang Hospital of Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
|
| Shenzhen Second People's Hospital | Not yet recruiting | Shenzhen | Guangdong | China |
|
| Zhongshan Hospital of Traditional Chinese Medicine | Not yet recruiting | Zhongshan | Guangdong | China |
|
| The First Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | China |
|
| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | China |
|
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
|
| Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | China |
|
| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
|
| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
|
| Affiliated Hospital of Nantong University | Not yet recruiting | Nantong | Jiangsu | China |
|
| The First Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | Jiangsu | China |
|
| 904 Hospital of the People's Liberation Army Joint Logistic Support Force | Not yet recruiting | Wuxi | Jiangsu | China |
|
| Affiliated Hospital of Yangzhou University | Not yet recruiting | Yangzhou | Jiangsu | China |
|
| Ganzhou People's Hospital | Not yet recruiting | Ganzhou | Jiangxi | China |
|
| The Second Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | China |
|
| The Fourth Affiliated Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | China |
|
| The Second Affiliated Hospital of Air Force Medical University | Not yet recruiting | Xi'an | Shaanxi | China |
|
| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | China |
|
| Renji Hospital, School of Medicine, Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Shanghai Donglei Brain Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Shanghai East Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| Shanghai Tenth People's Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| The Second Affiliated Hospital of Naval Medical University | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| West China Hospital, Sichuan University | Not yet recruiting | Chengdu | Sichuan | China |
|
| Inner Mongolia People's Hospital | Not yet recruiting | Hohhot | The Nei Monggol Autonomous Region | China |
|
| The First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang Uygur Autonomous Region | China |
|
| First Affiliated Hospital of Zhejiang University | Not yet recruiting | Hangzhou | Zhejiang | China |
|
| South taihu hospital affiliated to huzhou college | Recruiting | Huzhou | Zhejiang | China |
|
| The affiliated people's hospital of ningbo university | Not yet recruiting | Ningbo | Zhejiang | China |
|
| 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. |
| 33334204 | Background | 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. |
| 25687249 | Background | 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. |
| 30899767 | Background | 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. |
| 35250284 | Background | 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. |
| 30172065 | Background | 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. |
| 34095339 | Background | 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. |
| 28533993 | Background | 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. |
| 27219537 | Background | 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. |
| 29995267 | Background | 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. |
| 32087178 | Background | 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. |
| 37941074 | Background | 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. |
| 37209145 | Background | 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. |
| 33953433 | Background | 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. |
| 34775525 | Background | 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. |
| ID | Term |
|---|---|
| D002494 | Central Nervous System Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided