Clinical trial NCT03991052: Controlled MAP in the Brain Injury Patient (COMAT Study)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of California, Irvine
First posted: 2019-06-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: manual versus automated management of MAP
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: 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)

Eligibility criteria: 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)

Primary outcomes:
measure: Mean arterial pressure (MAP)
timeFrame: 48 hours post-admission in the intensive care unit
Secondary outcomes:
measure: Percentage of case time spent in Hypotension
timeFrame: 48 hours post-admission in the intensive care unit
measure: Percentage of case time spent Hypertension
timeFrame: 48 hours post-admission in the intensive care unit
measure: Cerebral perfusion pressure
timeFrame: 48 hours post-admission in the intensive care unit
measure: Intracranial pressure
timeFrame: 48 hours post-admission in the intensive care unit
measure: Intracranial pressure Hypertension
timeFrame: 48 hours post-admission in the intensive care unit
measure: Fluid received
timeFrame: 48 hours post-admission in the intensive care unit
measure: Amount of vasopressor
timeFrame: 48 hours post-admission in the intensive care unit
measure: Length of stay in the intensive care unit
timeFrame: 30 days post-admission in the intensive care unit
measure: mean arterial pressure (MAP)
timeFrame: 48 hours post-admission in the intensive care unit
measure: stroke volume
timeFrame: 48 hours post-admission in the intensive care unit
measure: cardiac index
timeFrame: 48 hours post-admission in the intensive care unit
measure: Transcranial doppler
timeFrame: 48 hours post-admission in the intensive care unit
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Bicêtre hospital
Study officials:
affiliation: Bicetre
name: Jacques DURANTEAU, MD, PhD
role: STUDY_CHAIR
References: