Ventricular irrigation to treat ventriculitis

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

This test will see if flushing infected brain ventricles (ventricular irrigation) helps adults with purulent ventriculitis recover faster and have fewer complications than standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 310 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 35 sites (Hefei, Anhui and 34 other locations)
• Trial ID: NCT06358209 on ClinicalTrials.gov

What this trial studies

Ventriculitis is a life-threatening infection of the brain’s ventricular system often associated with neurosurgical devices or procedures and with high mortality and long-term neurological disability. This interventional approach adds surgical ventricular irrigation—flushing and clearing pus from the ventricles, typically via external ventricular access—to standard antimicrobial therapy. The trial enrolls adults with purulent CSF (cloudy or yellow fluid with very high white blood cell counts), fever, and either positive CSF microbiology or CT/MRI evidence of intraventricular pus. Multiple hospitals in Anhui, China, led by RenJi Hospital and academic collaborators will track safety, infection clearance, mortality, and functional neurological outcomes.

Who should consider this trial

Good fit: Adults 18–65 with purulent CSF (cloudy/yellow) and WBC >1000×10^6/L, fever, and either positive CSF microbiology or CT/MRI evidence of intraventricular pus who can tolerate surgical intervention and give consent.

Not a fit: Patients unlikely to benefit include those with a Glasgow Coma Scale of 3, unstable vital signs (no spontaneous breathing or needing pressors), severe bleeding risk that precludes surgery, and pregnant or lactating women.

Why it matters

Potential benefit: If successful, ventricular irrigation could speed clearance of infection, lower mortality, and reduce long-term neurological disability in patients with purulent ventriculitis.

How similar studies have performed: Several recent case series and observational studies suggest ventricular irrigation can speed infection control and may improve outcomes, but high-quality randomized evidence is still limited.

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

Where this trial is running

Hefei, Anhui and 34 other locations

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (Not_yet_recruiting)
• The Second People's Hospital of Anhui Province — Hefei, Anhui, China (Not_yet_recruiting)
• The First Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Not_yet_recruiting)
• Xuanwu Hospital Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Not_yet_recruiting)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Zhongshan Hospital of Traditional Chinese Medicine — Zhongshan, Guangdong, China (Not_yet_recruiting)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
• 904 Hospital of the People's Liberation Army Joint Logistic Support Force — Wuxi, Jiangsu, China (Not_yet_recruiting)
• Affiliated Hospital of Yangzhou University — Yangzhou, Jiangsu, China (Not_yet_recruiting)
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The Fourth Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Air Force Medical University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Not_yet_recruiting)
• Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai Donglei Brain Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Naval Medical University — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• Inner Mongolia People's Hospital — Hohhot, The Nei Monggol Autonomous Region, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang Uygur Autonomous Region, China (Not_yet_recruiting)
• First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• South taihu hospital affiliated to huzhou college — Huzhou, Zhejiang, China (Recruiting)
• The affiliated people's hospital of ningbo university — Ningbo, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Jiyao Jiang, Dr — Renji Hospital, School of Medicine, Shanghai Jiaotong University
• Study coordinator: Jiyao Jiang, Dr

Conditions Central Nervous System Infections; Ventriculitis; Ventricular irrigation