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Completed

NCT Number: NCT03991052

Controlled MAP in the Brain Injury Patient (COMAT Study)

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)

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bicêtre hospital

Le Kremlin-Bicêtre, 94270, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EV1000 and closed-loop system

Device

This system will recommend when patients need fluid or not and adjust vasopressor administration automatically by the closed-loop system

Control group

Device

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

Primary outcomes

  1. Mean arterial pressure (MAP)

    Time frame: 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 outcomes

  1. Percentage of case time spent in Hypotension

    Time frame: 48 hours post-admission in the intensive care unit

    percentage time spent with MAP below 5 mmHg of the predefined MAP

  2. Percentage of case time spent Hypertension

    Time frame: 48 hours post-admission in the intensive care unit

    percentage time spent with MAP above 5 mmHg of the predefined MAP

  3. Cerebral perfusion pressure

    Time frame: 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)

  4. Intracranial pressure

    Time frame: 48 hours post-admission in the intensive care unit

    Measure of intracranial pressure during the treatment time (evolution over time)

  5. Intracranial pressure Hypertension

    Time frame: 48 hours post-admission in the intensive care unit

    percentage of intracranial pressure over 20 mmHg during the treatment period

  6. Fluid received

    Time frame: 48 hours post-admission in the intensive care unit

    comparison of amount of fluid received during the treatment period

  7. Amount of vasopressor

    Time frame: 48 hours post-admission in the intensive care unit

    amount of vasopressor received during the treatment period

  8. Length of stay in the intensive care unit

    Time frame: 30 days post-admission in the intensive care unit

    comparison of the length of stay in the intensive care unit between both groups.

  9. mean arterial pressure (MAP)

    Time frame: 48 hours post-admission in the intensive care unit

    MAP over the treatment period

  10. stroke volume

    Time frame: 48 hours post-admission in the intensive care unit

    stroke volume over the treatment period

  11. cardiac index

    Time frame: 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

  12. Transcranial doppler

    Time frame: 48 hours post-admission in the intensive care unit

    measure of mean cerebral velocity of mean cerebral artery

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • University of California, Irvine
  • University of California, Los Angeles

Registry information

Official study 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

Acronym: COMAT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2019
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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