None listed
Conditions
Brief summary
Neurosurgical patients are at a high risk of nosocomial bacterial meningitis (NBM), which results in high morbidity and mortality. Except antibiotic treatment, few therapeutic approaches have been proven to be effective in the treatment of NBM. Therefore, new therapeutic approaches need to be explored. Patients with bacterial meningitis usually present with abnormal characteristics of cerebrospinal fluid (CSF), including elevated white cell count, increased protein concentration, and reduced glucose level. The abnormal CSF constitutes a noxious stimulus to central nervous system and arouses a series of clinical manifestations including fever, nuchal stiffness, and impaired consciousness. Therefore, we suppose that drainage of abnormal CSF may lead to more rapid resolution of clinical manifestations or even a higher probability of a cure. This study aims to evaluate the role of lumbar drainage as an adjunctive treatment to antibiotic therapy in the treatment of post-neurosurgical nosocomial bacterial meningitis.
Interventions
Enrolled subjects will receive antibiotic therapy combined with continuous lumbar drainage. The procedure of lumbar drainage will be performed at bedside or in an operating room, which will take about 30-45 minutes. After that, continuous cerebrospinal fluid drainage will be maintained at a target draining speed of 8-12 mL/h throughout antibiotic treatment which is approximately 7-10 days. Cellular, biochemical, and microbial analysis of cerebrospinal fluid will be performed daily. The choice of
Enrolled subjects will receive antibiotic therapy combined with continuous lumbar drainage. The procedure of lumbar drainage will be performed at bedside or in an operating room, which will take about 30-45 minutes. After that, continuous cerebrospinal fluid drainage will be maintained at a target draining speed of 8-12 mL/h throughout antibiotic treatment which is approximately 7-10 days. Cellular, biochemical, and microbial analysis of cerebrospinal fluid will be performed daily. The choice of antibiotic agents is dependent on the result from bacterial antibiotic resistant tests. Antibiotic agents will mainly be used intravenously, and their dosage and frequency will stick to the recommendations from the manufacturers. As for vancomycin and gentamicin which have weak permeability into cerebrospinal fluid, intrathecal administration of vancomycin 20 mg or gentamicin 8mg will be used once daily through the draining catheter. One-hour clamping of the draining catheter is mandatory after intrathecal administration.
Sponsors
Ke Wang
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(1) postoperative or post-traumatic patients with nosocomial bacterial meningitis diagnosed by clinical manifestations in combination with positive results from cerebrospinal fluid culture and/or Gram's staining; (2) No clinical or radiographic signs of impending brain herniation;(3) informed consent is obtained from family members
Exclusion criteria
(1) Failure to obtain informed consent; (2) Patients with unremovable infected neurosurgical devices; (3) Presence of coagulation disorders or thrombocytopenia ; (4) Presence of chronic heart failure, respiratory insufficiency, liver dysfunction or renal impairment ; (5) Patients on immunosuppressors;(6) Pregnancy
Outcome results
None listed