NCT03991052

Controlled MAP in the Brain Injury Patient (COMAT Study)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Brain Injuries

Interventions

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

Timeline

• Start date: 2019-12-18
• Primary completion: 2021-07-07
• Completion: 2021-07-07
• First posted: 2019-06-19
• Last updated: 2023-05-30

Locations

1 site across 1 country: France