Controlled MAP in the Brain Injury Patient (COMAT Study)

Brain Injuries Clinical Trial

— COMAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991052
• Other study ID #: APHP180501
• Status: Completed
• Phase: N/A
• Start date: December 18, 2019
• Est. completion date: July 7, 2021

Study information

• Verified date: May 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 7, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Wounds and Injuries

Intervention

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
• Control group
This system will recommend when patients need fluid or not and nurses will adjust vasopressor administration as usual (standard of care)

Locations

Country	Name	City	State
France	Bicêtre hospital	Le Kremlin-Bicêtre

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	University of California, Irvine, University of California, Los Angeles

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Intracranial pressure	Measure of intracranial pressure during the treatment time (evolution over time)	48 hours post-admission in the intensive care unit
Secondary	Intracranial pressure Hypertension	percentage of intracranial pressure over 20 mmHg during the treatment period	48 hours post-admission in the intensive care unit
Secondary	Fluid received	comparison of amount of fluid received during the treatment period	48 hours post-admission in the intensive care unit
Secondary	Amount of vasopressor	amount of vasopressor received during the treatment period	48 hours post-admission in the intensive care unit
Secondary	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
Secondary	mean arterial pressure (MAP)	MAP over the treatment period	48 hours post-admission in the intensive care unit
Secondary	stroke volume	stroke volume over the treatment period	48 hours post-admission in the intensive care unit
Secondary	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
Secondary	Transcranial doppler	measure of mean cerebral velocity of mean cerebral artery	48 hours post-admission in the intensive care unit