The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in head trauma injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP compared to patients managed without any automated system (manually management)
In head trauma patients, the maintenance of MAP within a very narrow range is desired to avoid secondary ischemic diseases. 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 vasopressor infusion and/or fluid administration. Using a novel automated system can overcome this issue and may lead to more time in MAP target than the traditional management. All patients will have the same automated system for fluid administration using the EV1000 monitoring using the AFM mode ( Assisted fluid management). This system will recommend to the clinical when to administer a fluid bolus to optimize SV and SVV. So fluid administration will be standardized in both groups. The only difference will be the management of MAP. The goal will be to compare a treatment period of at least 3 hours during which the patient will be under continuous noradrenaline infusion. This treatment time should be within the first 48 hours of patient admission in the Intensive care unit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
This system will recommend when patients need fluid or not and adjust vasopressor administration automatically
Joosten Alexandre
Paris, LE Kremlin Bicetre, France
MEAN ARTERIAL PRESSURE (MAP)
time when MAP will be in the predefined range (+/- 5mmHg of the predefined MAP). This target can changed over the 48 hours of patient management due to increased intracranial pressure. This target is predefined by the clinician in charge of the patient and not involved in the study.
Time frame: 48 hours post-admission in the intensive care
Hypotension incidence
percentage time spent with MAP is below 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission
Time frame: 48 hours post-admission in the intensive care
Hypertension incidence
percentage time spent with MAP is above 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission
Time frame: 48 hours post-admission in the intensive care
Pulsatility index
measure of pulsatility index using the Transcranial doppler ultrasound
Time frame: baseline (admission to the intensive care unit)
Pulsatility index
measure of pulsatility index using the Transcranial doppler ultrasound
Time frame: 24 hours post-admission to the intensive care unit
Pulsatility index
measure of pulsatility index using the Transcranial doppler ultrasound
Time frame: 48 hours post-admission to the intensive care unit
Mean velocity
measure of mean velocity using the Transcranial doppler ultrasound
Time frame: baseline (admission to the intensive care unit)
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Mean velocity
measure of mean velocity using the Transcranial doppler ultrasound
Time frame: 24 hours post-admission to the intensive care unit
Mean velocity
measure of mean velocity using the Transcranial doppler ultrasound
Time frame: 48 hours post-admission to the intensive care unit
diastolic velocity
measure of diastolic velocity using the Transcranial doppler ultrasound
Time frame: baseline (admission to the intensive care unit)
Diastolic velocity
measure of diastolic velocity using the Transcranial doppler ultrasound
Time frame: 24 hours post-admission to the intensive care unit
Diastolic velocity
measure of diastolic velocity using the Transcranial doppler ultrasound
Time frame: 48 hours post-admission to the intensive care unit
Fluid received
comparison of amount of fluid received during the first 48 hours post admission
Time frame: 48 hours post-admission in the intensive care
Amount of vasopressor
amount of vasopressor received during the first 48 hours post admission
Time frame: 48 hours post-admission in the intensive care
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
Mean arterial pressure (MAP)
MAP over the first 48 hours postadmission in the intensive care
Time frame: 48 hours post-admission in the intensive care
Stroke volume
stroke volume over the first 48 hours postadmission in the intensive care
Time frame: 48 hours post-admission in the intensive care
cardiac index
cardiac index over the first 48 hours postadmission in the intensive care
Time frame: 48 hours post-admission in the intensive care