Clinical trial NCT03792581: COntrolled MAp Trauma Brain Injury (COMAT Study)
Official title: Individualizing Mean Arterial Pressure of Head Trauma Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Closed-Loop Communication
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: Bicetre Hospital
name: University of California, Irvine
name: University of California, Los Angeles
First posted: 2019-01-03
Enrollment: 0
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 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)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Severe Head trauma Patients ( Glasgow score ≤8), intubated, ventilated and sedated

Exclusion Criteria:

* Glasgow score \>8
* Bilateral mydriasis at the initial management

Primary outcomes:
measure: MEAN ARTERIAL PRESSURE (MAP)
timeFrame: 48 hours post-admission in the intensive care
Secondary outcomes:
measure: Hypotension incidence
timeFrame: 48 hours post-admission in the intensive care
measure: Hypertension incidence
timeFrame: 48 hours post-admission in the intensive care
measure: Pulsatility index
timeFrame: baseline (admission to the intensive care unit)
measure: Pulsatility index
timeFrame: 24 hours post-admission to the intensive care unit
measure: Pulsatility index
timeFrame: 48 hours post-admission to the intensive care unit
measure: Mean velocity
timeFrame: baseline (admission to the intensive care unit)
measure: Mean velocity
timeFrame: 24 hours post-admission to the intensive care unit
measure: Mean velocity
timeFrame: 48 hours post-admission to the intensive care unit
measure: diastolic velocity
timeFrame: baseline (admission to the intensive care unit)
measure: Diastolic velocity
timeFrame: 24 hours post-admission to the intensive care unit
measure: Diastolic velocity
timeFrame: 48 hours post-admission to the intensive care unit
measure: Fluid received
timeFrame: 48 hours post-admission in the intensive care
measure: Amount of vasopressor
timeFrame: 48 hours post-admission in the intensive care
measure: Length of stay in the Intensive care unit
timeFrame: 30 days post-admission in the intensive care
measure: Mean arterial pressure (MAP)
timeFrame: 48 hours post-admission in the intensive care
measure: Stroke volume
timeFrame: 48 hours post-admission in the intensive care
measure: cardiac index
timeFrame: 48 hours post-admission in the intensive care
Other outcomes:
Locations:
city: Paris
country: France
facility: Joosten Alexandre
state: LE Kremlin Bicetre
Study officials:
affiliation: APHP
name: Jacques Duranteau, PhD
role: STUDY_DIRECTOR
References: