None listed
Conditions
Brief summary
Lower respiratory tract (chest) infections are a common complication in patients placed onto mechanical ventilation (life support) in the intensive care unit (ICU). Patients with brain injuries who require invasive mechanical ventilation may be particularly susceptible to chest infections – the consequence of which may be worsening of their neurological injury. A recent multi-centre randomised clinical trial showed a significant reduction in ventilator associated pneumonia in mechanically ventilated patients after out of hospital cardiac arrest who received prophylactic (preventative) antibiotics starting within 6 hours of cardiac arrest. It is possible that patients with acute brain injuries would also benefit from this strategy as indicated by small pilot studies but it is not known whether this will lead to patient important outcomes such as increased survival with a favourable neurological outcome. This study aims to answer the question, do prophylactic antibiotics reduce the occurrence of lower respiratory tract infections in adults with acute neurological injuries requiring mechanical ventilation. This will then inform the design of a phase 3 trial testing the hypothesis that this treatment regime will increase survival with a favourable outcome at day 180 in these patients.
Interventions
Study treatments will be commenced as soon as possible following randomisation. Patients allocated to the intervention group will receive four doses of 1 gram of ceftriaxone made up to a total of 100mL in 0.9% sodium chloride administered intravenously 12 hours apart.
Administration of each dose of study drug will be recorded. If is not given in adherence with the protocol, a protocol deviation will be logged. Auditing against the medication chart is not planned.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged greater than or equal to 18 years AND 2. Invasively mechanically ventilated with one or more of the following acute brain injuries/conditions: (i) Ischaemic stroke (ii) Intracerebral haemorrhage (iii) Status epilepticus (iv) Subarachnoid haemorrhage (v) Suspected hypoxic ischaemic encephalopathy following resuscitation from cardiac arrest (vi) Traumatic brain injury. AND 3. Expected to be invasively ventilated (via endotracheal tube or tracheostomy) in the ICU until at least the day after tomorrow.
Exclusion criteria
1. Being treated with antibiotics to treat a known or suspected infection 2. Has been treated with antibiotics for a known or suspected infection in the previous 7 days 3. On prophylactic antibiotics except for peri-operative prophylaxis with cephazolin (or the treating clinician intends administering prophylactic antibiotics apart from peri-operative prophylaxis with cephazolin.) (SDD is counted as prophylactic antibiotics for the purposes of this exclusion) 4. More than 12 hours since intubation (or tracheostomy insertion) 5. More than 72 hours since hospital admission 6. Documented allergy or other contraindication to ceftriaxone 7. Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient or the substitute decision maker are not committed to full active treatment.
Outcome results
None listed