Controlled MAP in the Brain Injury Patient (COMAT Study)

Not Applicable

Completed

• Conditions: Brain Injuries

• Registration Number: NCT03991052
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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)

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Study Start: 2019-12-18
• Primary Completion: 2021-07-07
• Study Completion: 2021-07-07
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean arterial pressure (MAP)	48 hours post-admission in the intensive care unit	percentage of treatment time when MAP will be in the predefined range (+/- 5 mmHg of the target MAP)

Secondary Outcome Measures

Name	Time	Method
Percentage of case time spent in Hypotension	48 hours post-admission in the intensive care unit	percentage time spent with MAP below 5 mmHg of the predefined MAP
stroke volume	48 hours post-admission in the intensive care unit	stroke volume over the treatment period
cardiac index	48 hours post-admission in the intensive care unit	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
Transcranial doppler	48 hours post-admission in the intensive care unit	measure of mean cerebral velocity of mean cerebral artery
Fluid received	48 hours post-admission in the intensive care unit	comparison of amount of fluid received during the treatment period
Percentage of case time spent Hypertension	48 hours post-admission in the intensive care unit	percentage time spent with MAP above 5 mmHg of the predefined MAP
Cerebral perfusion pressure	48 hours post-admission in the intensive care unit	Measure of Cerebral perfusion pressure during the treatment time (evolution of Cerebral perfusion pressure over time)
Intracranial pressure Hypertension	48 hours post-admission in the intensive care unit	percentage of intracranial pressure over 20 mmHg during the treatment period
Intracranial pressure	48 hours post-admission in the intensive care unit	Measure of intracranial pressure during the treatment time (evolution over time)
mean arterial pressure (MAP)	48 hours post-admission in the intensive care unit	MAP over the treatment period
Amount of vasopressor	48 hours post-admission in the intensive care unit	amount of vasopressor received during the treatment period
Length of stay in the intensive care unit	30 days post-admission in the intensive care unit	comparison of the length of stay in the intensive care unit between both groups.

Trial Locations

Locations (1)

Bicêtre hospital; 🇫🇷 Le Kremlin-Bicêtre, France