None listed
Conditions
Brief summary
External ventricular drain (EVD) catheters are integral to the management of patients with severe traumatic brain injury (TBI). EVDs are routinely used in the management of severe TBI, and are recommended by international consensus guidelines. These catheters monitor and can help to lower the pressure within the brain that is often raised as a result of the brain injury. This process is not without risks. The EVD catheter provides a pathway between the brain and the external environment, which can become colonised by bacteria and lead to infection in the brain, called 'meningitis' or 'ventriculitis'. This infection may worsen brain damage, produce seizures, and increase length of stay in the hospital. One potential way of reducing this risk of EVD-associated infection is to use antibiotic-impregnated catheters. These EVDs release antibiotics over time, with the aim of preventing bacteria from contaminating the drains. Despite previous research it is still unclear if there is benefit to using these drains, which are considerably more expensive than the standard EVDs. The aim of this project is to determine if antibiotic-impregnated EVDs reduce the rates of infection in patients with TBI. In this study, patients with TBI who are planned for EVD insertion will have a 50:50 chance (like flipping a coin) to receive either a standard or antibiotic-impregnated EVD. After insertion, patients will be monitored until the EVD is removed (generally within 10 days following injury) to see if they develop catheter-associated infection. Results will then be compared to see if there is a difference between each group.
Interventions
An external ventricular drain (EVD) can be inserted by a neurosurgeon into the fluid-filled ventricles within the brain for the management of hydrocephalus and intracranial hypertension, and for intracranial pressure monitoring in traumatic brain injury. After the hydrocephalus or intracranial hypertension has resolved (usually within 2 weeks) the EVD can be removed or replaced. Timing of EVD removal is determined by the treating neurosurgical and intensive care teams.
Currently there are both
An external ventricular drain (EVD) can be inserted by a neurosurgeon into the fluid-filled ventricles within the brain for the management of hydrocephalus and intracranial hypertension, and for intracranial pressure monitoring in traumatic brain injury. After the hydrocephalus or intracranial hypertension has resolved (usually within 2 weeks) the EVD can be removed or replaced. Timing of EVD removal is determined by the treating neurosurgical and intensive care teams. Currently there are both standard, and antibiotic- (rifampicin and clindamycin) impregnated (Bactiseal™) catheters in use, without clear evidence of benefit. This trial will compare antibiotic-impregnated EVDs to standard silicon EVDs.
Sponsors
The Alfred, Intensive Care Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged at least 16 years old 2. Traumatic brain injury requiring external ventricular drain insertion
Exclusion criteria
1. Known or suspected CSF infection at time of EVD insertion 2. Any other indication for ongoing antibiotics at the time of EVD insertion 3. Prior EVD insertion (last 30 days) 4. Sepsis, ventriculitis, meningitis, skin infection at implantation site. 5. Allergy to Rifampicin and Clindamycin 6. Multiple EVDs required con-currently
Outcome results
None listed