The principal objective of this study is to compare the incidence of ventriculostomy related infections (VRIs) in patients who receive twenty-four hours of antibiotics, beginning no more than sixty minutes prior to EVD placement, to the incidence of VRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain (EVD). At this time, the duration of prophylactic antibiotic use with antibiotic impregnated EVDs is unknown.
Intracranial hemorrhage (ICH), which include subarachnoid hemorrhage (SAH), intraparenchymal hemorrhage (IPH) and intraventricular hemorrhage (IVH) affects nearly 30,000 every year in US alone. Despite rapid advances in treatment of just one of these pathologies, SAH, the case fatality rate remains at 32.2% in US. Successful post interventional outcome of patients suffering from SAH depends on the management of a multitude of secondary neurological complications, including prevention of re-hemorrhage, vasospasm, hydrocephalus, increased intracranial pressure (ICP), and seizure. A major component of this care is placement of an external ventricular drain (EVD), which is routine in patients suffering from SAH to manage ICP and to treat hydrocephalus. Placement of an EVD, however, is not without risk, in particular with regards to infection, commonly referred to as Ventriculostomy Related Infection (VRI). The rate of VRIs has been reported to range widely from 0% to 40% however, with an increased risk in patients suffering from hemorrhage or any vascular diseases (28.6%) in this subgroup, while typically lower (18.5%) in patients suffering from other neurosurgical diagnoses. Ventriculostomy related infections have been associated with increased delayed cerebral ischemia (a.k.a.; vasospasm), extended hospital duration, increased mortality and higher hospital costs. Despite the importance of management and prevention of VRIs, there hasn't been any clear consensus on administration of antibiotics post-procedurally. This is perpetuated by the fact that each institution, and even providers within institutions, have varying definitions of VRIs, and their own protocols regarding administration of antibiotics. Although there is an established protocol for insertion of EVD, which include pre-procedural intravenous antibiotic administration, there is no consensus on duration of post-operative antibiotics, despite the fact that successful patient outcomes depend on management of these VRIs. Further complicating the problem is the growing concern over increasing resistance to gram-positive organisms due to overuse of systemic antibiotics, as well as development of Clostridium difficile infection. As a result, practice is quite variable, based upon individual clinician preferences, rather than evidence based. Determining optimal strategies and protocols to minimize the incidence of VRI, while ensuring responsible antibiotic usage, thereby minimizing their deleterious effects on both individuals and communities, is of chief interest. These universal concerns and questions deserve a new formal study in this initial feasibility study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
VRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain. Nafcillin 1-2 grams every 6 hours (depending on weight) until the EVD is removed. If penicillin allergic, Doxycycline 100mg every 12 hours until the EVD is removed.
Nafcillin 1-2 grams every 6 hours (depending on weight) for a total of 24 hours. If penicillin allergic, Doxycycline 100mg every 12 hours for a total of 24 hours.
Montefiore Medical Center
The Bronx, New York, United States
RECRUITINGNumber of Participants with Cerebrospinal Fluid Positive (CSF+) VRI
A VRI will be defined as an infection of the CNS including abscess (when occurring after EVD placement), ventriculitis, or meningitis. To receive a diagnosis of meningitis or ventriculitis, NHSN criteria (1) OR (2) must be met: 1. Patient has organism(s) identified from CSF by a culture or non-culture based microbiological method (PCR) performed for purposes of clinical diagnosis or treatment OR 2. Patient has 2 or more of: 1. fever (\>38.0°C) or headache 2. meningeal sign(s) 3. cranial nerve sign(s) AND 1 or more of: 4. increased white cells, elevated protein, and decreased glucose in CSF (per reporting lab's reference range) 5. organism(s) seen on Gram stain of CSF 6. organism(s) identified from blood by a culture or non-culture based microbiologic testing method performed for purposes of clinical diagnosis or treatment (not Active Surveillance Culture/Testing) 7. diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Class of infecting organism
Class of infecting organisms identified will be summarized by study arm to assess whether the infections that occur in both treatment groups are caused by the same type of pathogen. The class of infecting organism will be summarized by study arm.
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Time to infection
Time to infection will be assessed from the time of EVD placement until discharge. Results will be summarized by study arm using descriptive statistics.
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Number of attempts at EVD catheter insertion
The number of attempts to insert the catheter will be evaluated. This outcome will be used to determine any subsequent effect catheter placement may have had on incidence of infection for each treatment modality. The number of placement attempts will be summarized by study arm.
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Incidence of nosocomial infections
The incidence of nosocomial infections of C. difficile or other multidrug resistant nosocomial infections in participants will be evaluated. Incidence in the context of this study will equal the number of new EVD-related infections divided by the total EVD days at risk and expressed as a percentage. Results will be summarized by study arm using descriptive statistics.
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Overall Morbidity
Overall morbidity, defined as morbidity from all causes, will be determined. This will include any morbidity from high grade fever (\>101 degrees Fahrenheit), repositioning of EVD, post procedural hemorrhage, or new catheter placement due to new bleeding (at a different location than original), or need for permanent CSF drainage (i.e. ventriculoperitoneal shunt). Morbidity will be summarized by study arm.
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Overall Mortality
Overall mortality, defined as mortality from all causes, will be determined. Mortality along with cause of death will be recorded and summarized for patients who die during the period of insertion of EVD until one week after its removal.
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
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