severe traumatic brain injury (TBI)
Conditions
Interventions
Control group: Standard care.
This means: Patients are managed according to recent international trauma
foundation guidelines with keeping CPP between 60 and 70 mmHg. Individual and
flexible CPP in
Cerebral autoregulation
Cerebral monitoring
Cerebral perfusion management
Traumatic brain injury
Sponsors
Intensive Care
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Any adult severe TBI patient requiring ICP monitoring and ICP/CPP directed therapy for at least 24 hrs on the assessment of the recruiting team - Start randomization within 24 hrs after ICU admission
Exclusion criteria
Exclusion criteria: - Patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of monitoring time with measured CPP within 5 mmHg of calculated individual and flexible CPP (CPPopt). Time Frame: First 5 days during intensive care unit admission In pilot studies, we showed that, on average, patients spent a mean (+SD) of 30% (8%) of their monitored time with measured CPP within 5 mmHg of CPPopt. The study will be powered to target an increase in this metric to 50% of monitored time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Main secondary endpoint: Daily Treatment Intensity Level (TIL) score (0-48 points). Time Frame: First 5 days during intensive care unit admission. A change in daily TIL score of > 3 is representative of a clinical significant escalation of TBI treatment from basic ICP management to second tier therapies known to carry risk of harm and therefore is expected to represent a clinically significant potentially harmful effect of CPPopt guided management. Other secondary endpoints: data like systemic (like arterial blood pressure) and cerebral physiological values (like intracranial pressure and autoregulation status), used medications, (laboratory) markers of organ damage (heart, kidney, lungs), electrocardiograms, daily lung x-rays and diagnostic follow up imaging (mainly CT cerebrum) are collected for effectiviness and safety endpoints. For these secondary endpoints no extra measurements (blood results/scans) have to be done (already part of clinical routine). | — |
Countries
The Netherlands
Outcome results
None listed