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)

Study Overview

• Status: Completed
• Conditions: Brain Injuries
• Intervention / Treatment: Device: Control group; Device: EV1000 and closed-loop system

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandre JOOSTEN, MD, PhD; Phone Number: 0033145212121; Email: alexandre.joosten@aphp.fr
• Study Contact Backup: Name: Jacques DURANTEAU, MD, PhD; Phone Number: 0033145212121; Email: jacques.duranteau@aphp.fr

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94270
    • Bicetre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EV1000 monitor; 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	Device: Control group; This system will recommend when patients need fluid or not and nurses will adjust vasopressor administration as usual (standard of care)
Experimental: EV1000 monitor + closed-loop 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	Device: EV1000 and closed-loop system; This system will recommend when patients need fluid or not and adjust vasopressor administration automatically by the closed-loop system

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: University of California, Los Angeles; University of California, Irvine
• Investigators: Study Chair: Jacques DURANTEAU, MD, PhD, BICETRE

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Actual): July 7, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: APHP180501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No