<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03792581</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A02976-49</org_study_id>
    <nct_id>NCT03792581</nct_id>
  </id_info>
  <brief_title>COntrolled MAp Trauma Brain Injury (COMAT Study)</brief_title>
  <acronym>COMAT</acronym>
  <official_title>Individualizing Mean Arterial Pressure of Head Trauma Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasme University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bicetre Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Erasme University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this randomized controlled trial will be to show that the use of a novel&#xD;
      automated system to guide vasopressor administration in head trauma injury patients will&#xD;
      results in more time spent with a mean arterial pressure (MAP) within the predefined MAP&#xD;
      compared to patients managed without any automated system (manually management)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In head trauma patients, the maintenance of MAP within a very narrow range is desired to&#xD;
      avoid secondary ischemic diseases. However, the MAP needed to reach can vary over time based&#xD;
      on intracranial pressure. Additionally, it is well know that the nurses in the Intensive care&#xD;
      unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to&#xD;
      adjust vasopressor infusion and/or fluid administration. Using a novel automated system can&#xD;
      overcome this issue and may lead to more time in MAP target than the traditional management.&#xD;
&#xD;
      All patients will have the same automated system for fluid administration using the EV1000&#xD;
      monitoring using the AFM mode ( Assisted fluid management). This system will recommend to the&#xD;
      clinical when to administer a fluid bolus to optimize SV and SVV. So fluid administration&#xD;
      will be standardized in both groups. The only difference will be the management of MAP.&#xD;
&#xD;
      The goal will be to compare a treatment period of at least 3 hours during which the patient&#xD;
      will be under continuous noradrenaline infusion. This treatment time should be within the&#xD;
      first 48 hours of patient admission in the Intensive care unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The sponsor was not the good one. We will redo the clincal trial gov to be concordant with the&#xD;
    actual sponsor&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Manual versus automated management of MAP</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MEAN ARTERIAL PRESSURE (MAP)</measure>
    <time_frame>48 hours post-admission in the intensive care</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypotension incidence</measure>
    <time_frame>48 hours post-admission in the intensive care</time_frame>
    <description>percentage time spent with MAP is below 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertension incidence</measure>
    <time_frame>48 hours post-admission in the intensive care</time_frame>
    <description>percentage time spent with MAP is above 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulsatility index</measure>
    <time_frame>baseline (admission to the intensive care unit)</time_frame>
    <description>measure of pulsatility index using the Transcranial doppler ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulsatility index</measure>
    <time_frame>24 hours post-admission to the intensive care unit</time_frame>
    <description>measure of pulsatility index using the Transcranial doppler ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulsatility index</measure>
    <time_frame>48 hours post-admission to the intensive care unit</time_frame>
    <description>measure of pulsatility index using the Transcranial doppler ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean velocity</measure>
    <time_frame>baseline (admission to the intensive care unit)</time_frame>
    <description>measure of mean velocity using the Transcranial doppler ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean velocity</measure>
    <time_frame>24 hours post-admission to the intensive care unit</time_frame>
    <description>measure of mean velocity using the Transcranial doppler ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean velocity</measure>
    <time_frame>48 hours post-admission to the intensive care unit</time_frame>
    <description>measure of mean velocity using the Transcranial doppler ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diastolic velocity</measure>
    <time_frame>baseline (admission to the intensive care unit)</time_frame>
    <description>measure of diastolic velocity using the Transcranial doppler ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic velocity</measure>
    <time_frame>24 hours post-admission to the intensive care unit</time_frame>
    <description>measure of diastolic velocity using the Transcranial doppler ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic velocity</measure>
    <time_frame>48 hours post-admission to the intensive care unit</time_frame>
    <description>measure of diastolic velocity using the Transcranial doppler ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluid received</measure>
    <time_frame>48 hours post-admission in the intensive care</time_frame>
    <description>comparison of amount of fluid received during the first 48 hours post admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of vasopressor</measure>
    <time_frame>48 hours post-admission in the intensive care</time_frame>
    <description>amount of vasopressor received during the first 48 hours post admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in the Intensive care unit</measure>
    <time_frame>30 days post-admission in the intensive care</time_frame>
    <description>comparison of the length of stay in the Intensive care unit between both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial pressure (MAP)</measure>
    <time_frame>48 hours post-admission in the intensive care</time_frame>
    <description>MAP over the first 48 hours postadmission in the intensive care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke volume</measure>
    <time_frame>48 hours post-admission in the intensive care</time_frame>
    <description>stroke volume over the first 48 hours postadmission in the intensive care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac index</measure>
    <time_frame>48 hours post-admission in the intensive care</time_frame>
    <description>cardiac index over the first 48 hours postadmission in the intensive care</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Closed-Loop Communication</condition>
  <arm_group>
    <arm_group_label>EV1000 monitor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EV1000 monitor + closed-loop system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EV1000 and closed-loop system</intervention_name>
    <description>This system will recommend when patients need fluid or not and adjust vasopressor administration automatically</description>
    <arm_group_label>EV1000 monitor</arm_group_label>
    <arm_group_label>EV1000 monitor + closed-loop system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe Head trauma Patients ( Glasgow score ≤8), intubated, ventilated and sedated&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Glasgow score &gt;8&#xD;
&#xD;
          -  Bilateral mydriasis at the initial management&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacques Duranteau, PhD</last_name>
    <role>Study Director</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Joosten Alexandre</name>
      <address>
        <city>Paris</city>
        <state>LE Kremlin Bicetre</state>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>May 10, 2019</last_update_submitted>
  <last_update_submitted_qc>May 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasme University Hospital</investigator_affiliation>
    <investigator_full_name>Alexandre Joosten</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03792581
org study id: 2018-A02976-49
nct id: NCT03792581
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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)
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Manual versus automated management of MAP
primary purpose: Treatment
masking: Single (Participant)
measure: MEAN ARTERIAL PRESSURE (MAP)
time frame: 48 hours post-admission in the intensive care
description: 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.
measure: Hypotension incidence
time frame: 48 hours post-admission in the intensive care
description: percentage time spent with MAP is below 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission
measure: Hypertension incidence
time frame: 48 hours post-admission in the intensive care
description: percentage time spent with MAP is above 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission
measure: Pulsatility index
time frame: baseline (admission to the intensive care unit)
description: measure of pulsatility index using the Transcranial doppler ultrasound
measure: Pulsatility index
time frame: 24 hours post-admission to the intensive care unit
description: measure of pulsatility index using the Transcranial doppler ultrasound
measure: Pulsatility index
time frame: 48 hours post-admission to the intensive care unit
description: measure of pulsatility index using the Transcranial doppler ultrasound
measure: Mean velocity
time frame: baseline (admission to the intensive care unit)
description: measure of mean velocity using the Transcranial doppler ultrasound
measure: Mean velocity
time frame: 24 hours post-admission to the intensive care unit
description: measure of mean velocity using the Transcranial doppler ultrasound
measure: Mean velocity
time frame: 48 hours post-admission to the intensive care unit
description: measure of mean velocity using the Transcranial doppler ultrasound
measure: diastolic velocity
time frame: baseline (admission to the intensive care unit)
description: measure of diastolic velocity using the Transcranial doppler ultrasound
measure: Diastolic velocity
time frame: 24 hours post-admission to the intensive care unit
description: measure of diastolic velocity using the Transcranial doppler ultrasound
measure: Diastolic velocity
time frame: 48 hours post-admission to the intensive care unit
description: measure of diastolic velocity using the Transcranial doppler ultrasound
measure: Fluid received
time frame: 48 hours post-admission in the intensive care
description: comparison of amount of fluid received during the first 48 hours post admission
measure: Amount of vasopressor
time frame: 48 hours post-admission in the intensive care
description: amount of vasopressor received during the first 48 hours post admission
measure: Length of stay in the Intensive care unit
time frame: 30 days post-admission in the intensive care
description: comparison of the length of stay in the Intensive care unit between both groups
measure: Mean arterial pressure (MAP)
time frame: 48 hours post-admission in the intensive care
description: MAP over the first 48 hours postadmission in the intensive care
measure: Stroke volume
time frame: 48 hours post-admission in the intensive care
description: stroke volume over the first 48 hours postadmission in the intensive care
measure: cardiac index
time frame: 48 hours post-admission in the intensive care
description: cardiac index over the first 48 hours postadmission in the intensive care
arm group label: EV1000 monitor
arm group type: Active Comparator
description: 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
arm group label: EV1000 monitor + closed-loop system
arm group type: Experimental
description: 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
intervention type: Device
intervention name: EV1000 and closed-loop system
description: This system will recommend when patients need fluid or not and adjust vasopressor administration automatically
arm group label: EV1000 monitor
arm group label: EV1000 monitor + closed-loop system
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jacques Duranteau, PhD
role: Study Director
affiliation: APHP
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Erasme University Hospital
investigator full name: Alexandre Joosten
investigator title: Principal Investigator
sharing ipd: Undecided