COntrolled MAp Trauma Brain Injury (COMAT Study) (COMAT)

Individualizing Mean Arterial Pressure of Head Trauma Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial

The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in head trauma injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP compared to patients managed without any automated system (manually management)

Study Overview

• Status: Withdrawn
• Conditions: Closed-Loop Communication
• Intervention / Treatment: Device: EV1000 and closed-loop system

Detailed Description

In head trauma patients, the maintenance of MAP within a very narrow range is desired to avoid secondary ischemic diseases. 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 vasopressor infusion and/or fluid administration. Using a novel automated system can overcome this issue and may lead to more time in MAP target than the traditional management.

All patients will have the same automated system for fluid administration using the EV1000 monitoring using the AFM mode ( Assisted fluid management). This system will recommend to the clinical when to administer a fluid bolus to optimize SV and SVV. So fluid administration will be standardized in both groups. The only difference will be the management of MAP.

The goal will be to compare a treatment period of at least 3 hours during which the patient will be under continuous noradrenaline infusion. This treatment time should be within the first 48 hours of patient admission in the Intensive care unit.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • LE Kremlin Bicetre
    • Paris, LE Kremlin Bicetre, France, 94275
      • Joosten Alexandre

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Severe Head trauma Patients ( Glasgow score ≤8), intubated, ventilated and sedated

Exclusion Criteria:

• Glasgow score >8
• Bilateral mydriasis at the initial management

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: EV1000 and closed-loop system; This system will recommend when patients need fluid or not and adjust vasopressor administration automatically
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MEAN ARTERIAL PRESSURE (MAP)	time when MAP will be in the predefined range (+/- 5mmHg of the predefined MAP). This target can changed over the 48 hours of patient management due to increased intracranial pressure. This target is predefined by the clinician in charge of the patient and not involved in the study.	48 hours post-admission in the intensive care

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypotension incidence	percentage time spent with MAP is below 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission	48 hours post-admission in the intensive care
Hypertension incidence	percentage time spent with MAP is above 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission	48 hours post-admission in the intensive care
Pulsatility index	measure of pulsatility index using the Transcranial doppler ultrasound	baseline (admission to the intensive care unit)
Pulsatility index	measure of pulsatility index using the Transcranial doppler ultrasound	24 hours post-admission to the intensive care unit
Pulsatility index	measure of pulsatility index using the Transcranial doppler ultrasound	48 hours post-admission to the intensive care unit
Mean velocity	measure of mean velocity using the Transcranial doppler ultrasound	baseline (admission to the intensive care unit)
Mean velocity	measure of mean velocity using the Transcranial doppler ultrasound	24 hours post-admission to the intensive care unit
Mean velocity	measure of mean velocity using the Transcranial doppler ultrasound	48 hours post-admission to the intensive care unit
diastolic velocity	measure of diastolic velocity using the Transcranial doppler ultrasound	baseline (admission to the intensive care unit)
Diastolic velocity	measure of diastolic velocity using the Transcranial doppler ultrasound	24 hours post-admission to the intensive care unit
Diastolic velocity	measure of diastolic velocity using the Transcranial doppler ultrasound	48 hours post-admission to the intensive care unit
Fluid received	comparison of amount of fluid received during the first 48 hours post admission	48 hours post-admission in the intensive care
Amount of vasopressor	amount of vasopressor received during the first 48 hours post admission	48 hours post-admission in the intensive care
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
Mean arterial pressure (MAP)	MAP over the first 48 hours postadmission in the intensive care	48 hours post-admission in the intensive care
Stroke volume	stroke volume over the first 48 hours postadmission in the intensive care	48 hours post-admission in the intensive care
cardiac index	cardiac index over the first 48 hours postadmission in the intensive care	48 hours post-admission in the intensive care

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Collaborators: University of California, Los Angeles; University of California, Irvine; Bicetre Hospital
• Investigators: Study Director: Jacques Duranteau, PhD, APHP

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: December 16, 2018
• First Submitted That Met QC Criteria: January 1, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018-A02976-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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