Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358209
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-31
Brief Title:
Safety and Efficacy of Ventricular Irrigation for Ventriculitis
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Safety and Efficacy of Ventricular Irrigation for Ventriculitis a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 severe ventriculitis analyze the effectiveness of ventricular irrigation across different pathogen subgroups and investigate independent risk factors for different prognostic states in patients with severe ventriculitis
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 severe ventriculitis analyze the effectiveness of ventricular irrigation across different pathogen subgroups and investigate independent risk factors for different prognostic states in patients with severe ventriculitis
Detailed Description:
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 severe ventriculitis analyze the effectiveness of ventricular irrigation across different pathogen subgroups and investigate independent risk factors for different prognostic states in patients with severe ventriculitis
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 severe ventriculitis analyze the effectiveness of ventricular irrigation across different pathogen subgroups and investigate independent risk factors for different prognostic states in patients with severe ventriculitis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None