The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in brain injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP (+/- 5 mmHg of the target MAP) compared to patients managed without any automated system (manually management)
In brain injury patients, the maintenance of MAP within a very narrow range is desired to avoid complications related to hypoperfusion (undertreatment) or hypertension (over treatment). However, the MAP needed to reach can vary over time based on intracranial pressure. Additionally, it is well know that the nurses in the Intensive care unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust drugs infusions. Using a novel automated system can overcome this issue and may lead to more time in MAP target (+/- 5mmHg) than the traditional management. After initial rescuscitation of the patients, patients in both groups will have the same baseline maintenance fluid administration of 1-2 ml/kg/h of crystalloid solution and additionnal fluid boluses administered following the EV1000 monitoring device. The only difference will be the management of vasopressor titration (manual by nurses vs automated via a closed-loop system)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
23
This system will recommend when patients need fluid or not and adjust vasopressor administration automatically by the closed-loop system
This system will recommend when patients need fluid or not and nurses will adjust vasopressor administration as usual (standard of care)
Bicêtre hospital
Le Kremlin-Bicêtre, France
Mean arterial pressure (MAP)
percentage of treatment time when MAP will be in the predefined range (+/- 5 mmHg of the target MAP)
Time frame: 48 hours post-admission in the intensive care unit
Percentage of case time spent in Hypotension
percentage time spent with MAP below 5 mmHg of the predefined MAP
Time frame: 48 hours post-admission in the intensive care unit
Percentage of case time spent Hypertension
percentage time spent with MAP above 5 mmHg of the predefined MAP
Time frame: 48 hours post-admission in the intensive care unit
Cerebral perfusion pressure
Measure of Cerebral perfusion pressure during the treatment time (evolution of Cerebral perfusion pressure over time)
Time frame: 48 hours post-admission in the intensive care unit
Intracranial pressure
Measure of intracranial pressure during the treatment time (evolution over time)
Time frame: 48 hours post-admission in the intensive care unit
Intracranial pressure Hypertension
percentage of intracranial pressure over 20 mmHg during the treatment period
Time frame: 48 hours post-admission in the intensive care unit
Fluid received
comparison of amount of fluid received during the treatment period
Time frame: 48 hours post-admission in the intensive care unit
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Amount of vasopressor
amount of vasopressor received during the treatment period
Time frame: 48 hours post-admission in the intensive care unit
Length of stay in the intensive care unit
comparison of the length of stay in the intensive care unit between both groups.
Time frame: 30 days post-admission in the intensive care unit
mean arterial pressure (MAP)
MAP over the treatment period
Time frame: 48 hours post-admission in the intensive care unit
stroke volume
stroke volume over the treatment period
Time frame: 48 hours post-admission in the intensive care unit
cardiac index
cardiac index over the treatment period. This will be the mean values over the procedure. Measurements recorded each 20 seconds and averaged for the procedure. The unit is l/min/m-2
Time frame: 48 hours post-admission in the intensive care unit
Transcranial doppler
measure of mean cerebral velocity of mean cerebral artery
Time frame: 48 hours post-admission in the intensive care unit