Controlled MAP in the Brain Injury Patient (COMAT Study) (COMAT)

Controlled Mean Arterial Pressure of Brain Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial in Critically Ill Patients in the Intensive Care Unit

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)

MAP management will be done as usual (adjustment by nurses) and fluid management will be managed using the EV1000 monitoring device with the automated decision support system

Fluid management will be done using the automated decision support system and MAP will be adjusted by the automated closed-loop system for vasopressor administration

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)

Measure of Cerebral perfusion pressure during the treatment time (evolution of Cerebral perfusion pressure over time)

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

Inclusion Criteria: severe brain injury patients (Glasgow score <9), intubated, ventilated and sedated. Exclusion Criteria: Glasgow score > 8 Bilateral mydriasis at the initial management (Ambulance and first hour of arrival)