<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/NCT03787732</url>
  </required_header>
  <id_info>
    <org_study_id>IRB# 181690</org_study_id>
    <nct_id>NCT03787732</nct_id>
  </id_info>
  <brief_title>Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation</brief_title>
  <acronym>PREPARE II</acronym>
  <official_title>Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation (PREPARE II Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Complications are common during tracheal intubation of critically ill patients. Nearly one in&#xD;
      five patients undergoing intubation in the intensive care unit experiences cardiovascular&#xD;
      collapse, defined as severe hypotension, vasopressor administration, cardiac arrest or death.&#xD;
      Cardiovascular collapse during intubation is associated with increased resource utilization&#xD;
      and decreased survival. Administration of 500 mL of intravenous crystalloid solution&#xD;
      beginning prior to induction may prevent cardiovascular collapse. The only prior trial&#xD;
      examining fluid bolus administration during intubation found no effect on cardiovascular&#xD;
      collapse or clinical outcomes overall, but a hypothesis-generating subgroup analysis&#xD;
      suggested potential benefit to fluid bolus administration among patients receiving positive&#xD;
      pressure ventilation between induction and laryngoscopy. Therefore, we propose a randomized&#xD;
      trial comparing fluid bolus administration versus none with regard to cardiovascular collapse&#xD;
      among critically adults undergoing intubation with positive pressure ventilation between&#xD;
      induction and laryngoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The PREPARE II trial is a prospective, parallel group, pragmatic, randomized trial comparing&#xD;
      the effect of a preintubation fluid bolus to no preintubation fluid bolus on the incidence of&#xD;
      cardiovascular collapse during and after endotracheal intubation in critically ill adults.&#xD;
&#xD;
      Patients admitted to the study units who are deemed by their clinical team to require&#xD;
      intubation and fulfill inclusion criteria without meeting exclusion criteria will be&#xD;
      randomized 1:1 to receive either an intravenous fluid bolus or no intravenous fluid bolus.&#xD;
      All other decisions regarding airway management will remain at the discretion of the treating&#xD;
      provider.&#xD;
&#xD;
      Conduct of the trial will be overseen by a Data Safety Monitoring Board. An interim analysis&#xD;
      will be performed after the enrollment of 375 patients. The analysis of the trial will be&#xD;
      conducted in accordance with a pre-specified statistical analysis plan, which will be&#xD;
      submitted for publication or made publicly available prior to the conclusion of enrollment.&#xD;
&#xD;
      The primary outcome is cardiovascular collapse - a composite endpoint defined as one or more&#xD;
      of the following:&#xD;
&#xD;
        1. Death within 1 hour of intubation&#xD;
&#xD;
        2. Cardiac arrest within 1 hour of intubation&#xD;
&#xD;
        3. New systolic blood pressure &lt; 65 mmHg between induction and 2 minutes after completion&#xD;
           of intubation&#xD;
&#xD;
        4. New or increased vasopressor receipt between induction and 2 minutes after completion of&#xD;
           intubation&#xD;
&#xD;
      The secondary outcome is 28-day in-hospital mortality&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">June 21, 2021</completion_date>
  <primary_completion_date type="Actual">May 24, 2021</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiovascular collapse</measure>
    <time_frame>1 hour</time_frame>
    <description>A composite endpoint defined as one or more of the following&#xD;
New systolic blood pressure &lt; 65 mmHg between induction and 2 minutes after intubation&#xD;
New or increased vasopressor between induction and 2 minutes after intubation&#xD;
Cardiac arrest within 1 hour of intubation&#xD;
Death within 1 hour of intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>28-day in-hospital mortality</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>New systolic blood pressure &lt; 65 mmHg between induction and 2 minutes after intubation</measure>
    <time_frame>from induction to 2 minutes following tracheal intubation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>New or increased vasopressor between induction and 2 minutes after intubation</measure>
    <time_frame>from induction to 2 minutes following tracheal intubation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac arrest within 1 hour of intubation</measure>
    <time_frame>1 hour</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Death within 1 hour of intubation</measure>
    <time_frame>1 hour</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Lowest systolic blood pressure between induction and 2 minutes after intubation</measure>
    <time_frame>from induction to 2 minutes following tracheal intubation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in systolic blood pressure from induction to lowest systolic blood pressure</measure>
    <time_frame>between induction and 2 minutes following procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Ventilator-free days</measure>
    <time_frame>28 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>ICU-free days</measure>
    <time_frame>28 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Lowest oxygen saturation</measure>
    <time_frame>from induction to 2 minutes following tracheal intubation</time_frame>
    <description>Lowest arterial oxygen saturation between induction and 2 minutes after intubation</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of hypoxemia</measure>
    <time_frame>from induction to 2 minutes following tracheal intubation</time_frame>
    <description>Incidence of oxygen saturation &lt; 90% between induction and 2 minutes after intubation</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of severe hypoxemia</measure>
    <time_frame>from induction to 2 minutes following tracheal intubation</time_frame>
    <description>Incidence of oxygen saturation &lt; 80% between induction and 2 minutes after intubation</description>
  </other_outcome>
  <other_outcome>
    <measure>Oxygen saturation at 24 hours after intubation</measure>
    <time_frame>24 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fraction of inspired oxygen at 24 hours after intubation</measure>
    <time_frame>24 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Positive end expiratory pressure at 24 hours after intubation</measure>
    <time_frame>24 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Systolic blood pressure at 24 hours after intubation</measure>
    <time_frame>24 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Additional intravenous fluids initiated between induction and 2 minutes after intubation</measure>
    <time_frame>from induction to 2 minutes following tracheal intubation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Time from induction to successful intubation</measure>
    <time_frame>Duration of procedure (minutes)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cormack-Lehane grade of glottic view on first attempt</measure>
    <time_frame>Duration of procedure (minutes)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Difficulty of intubation</measure>
    <time_frame>Duration of procedure (minutes)</time_frame>
    <description>Operator-reported difficulty of intubation on a three-point ordinal scale of: easy, moderate, or difficult.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of successful intubation on the first laryngoscopy attempt</measure>
    <time_frame>Duration of procedure (minutes)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of laryngoscopy attempts</measure>
    <time_frame>Duration of procedure (minutes)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Need for additional airway equipment or a second operator</measure>
    <time_frame>Duration of procedure (minutes)</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1067</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <condition>Intubation Complication</condition>
  <condition>Hypotension on Induction</condition>
  <arm_group>
    <arm_group_label>Fluid Bolus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For patients randomized to fluid bolus administration, the bedside nurse will obtain 500 mL of a crystalloid solution of the operator's choosing, connect this volume to intravenous infusion tubing, and attach the tubing to any intravenous catheter or intraosseous device. The crystalloid solution will then be placed above the level of the intravenous or intraosseous device and allowed to infuse by gravity or pressure bag. At any time after the initiation of fluid bolus administration, the operator can choose to begin the procedure by administering sedation. Fluid loading will continue until all 500 mL are infused. Fluid infusing prior to the decision to perform endotracheal intubation will not be altered by the current study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Fluid Bolus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For patients randomized to no fluid bolus administration, no additional intravenous crystalloid administration will be initiated between randomization and two minutes after completion of endotracheal intubation. Fluid infusing prior to the decision to perform endotracheal intubation will not be affected by the study. Treating clinicians may initiate a fluid bolus at any time for the treatment of cardiovascular collapse (not considered a protocol violation). Treating clinicians may also initiate a fluid bolus at any time if felt to be mandatory for the safe treatment of the patient (if between randomization and two minutes after intubation and in the absence of cardiovascular collapse this will be recorded as a protocol violation).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluid Bolus</intervention_name>
    <description>500 milliliters of an intravenous crystalloid solution of the operator's choosing</description>
    <arm_group_label>Fluid Bolus</arm_group_label>
    <other_name>intravenous crystalloid fluid, 500 mL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Fluid Bolus</intervention_name>
    <description>No additional intravenous crystalloid administration initiated between randomization and two minutes after completion of endotracheal intubation</description>
    <arm_group_label>No Fluid Bolus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is undergoing endotracheal intubation in a participating unit&#xD;
&#xD;
          2. Planned operator is a provider expected to routinely perform endotracheal intubation&#xD;
             in the participating unit&#xD;
&#xD;
          3. Patient is at least 18 years of age&#xD;
&#xD;
          4. Administration of sedation is planned (with or without neuromuscular blockade)&#xD;
&#xD;
          5. Positive pressure ventilation between induction and laryngoscopy is planned (e.g.,&#xD;
             non-invasive ventilation or bag-mask ventilation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prisoners&#xD;
&#xD;
          2. Pregnant patients&#xD;
&#xD;
          3. Urgency of intubation precludes safe performance of study procedures&#xD;
&#xD;
          4. Operator feels administration of a fluid bolus is indicated or contraindicated for the&#xD;
             safe performance of the procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David R Janz, MD, MSCI</last_name>
    <role>Principal Investigator</role>
    <affiliation>Louisiana State University Health Sciences Center in New Orleans</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Derek W Russell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana State University School of Medicine</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center | Ochsner Health System</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Hospital &amp; Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Medical Center - Temple</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>August 10, 2021</last_update_submitted>
  <last_update_submitted_qc>August 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Matthew Semler</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Intubation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Hypotension</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <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/NCT03787732
org study id: IRB# 181690
nct id: NCT03787732
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Complications are common during tracheal intubation of critically ill patients. Nearly one in
      five patients undergoing intubation in the intensive care unit experiences cardiovascular
      collapse, defined as severe hypotension, vasopressor administration, cardiac arrest or death.
      Cardiovascular collapse during intubation is associated with increased resource utilization
      and decreased survival. Administration of 500 mL of intravenous crystalloid solution
      beginning prior to induction may prevent cardiovascular collapse. The only prior trial
      examining fluid bolus administration during intubation found no effect on cardiovascular
      collapse or clinical outcomes overall, but a hypothesis-generating subgroup analysis
      suggested potential benefit to fluid bolus administration among patients receiving positive
      pressure ventilation between induction and laryngoscopy. Therefore, we propose a randomized
      trial comparing fluid bolus administration versus none with regard to cardiovascular collapse
      among critically adults undergoing intubation with positive pressure ventilation between
      induction and laryngoscopy.
The PREPARE II trial is a prospective, parallel group, pragmatic, randomized trial comparing
      the effect of a preintubation fluid bolus to no preintubation fluid bolus on the incidence of
      cardiovascular collapse during and after endotracheal intubation in critically ill adults.

      Patients admitted to the study units who are deemed by their clinical team to require
      intubation and fulfill inclusion criteria without meeting exclusion criteria will be
      randomized 1:1 to receive either an intravenous fluid bolus or no intravenous fluid bolus.
      All other decisions regarding airway management will remain at the discretion of the treating
      provider.

      Conduct of the trial will be overseen by a Data Safety Monitoring Board. An interim analysis
      will be performed after the enrollment of 375 patients. The analysis of the trial will be
      conducted in accordance with a pre-specified statistical analysis plan, which will be
      submitted for publication or made publicly available prior to the conclusion of enrollment.

      The primary outcome is cardiovascular collapse - a composite endpoint defined as one or more
      of the following:

        1. Death within 1 hour of intubation

        2. Cardiac arrest within 1 hour of intubation

        3. New systolic blood pressure < 65 mmHg between induction and 2 minutes after completion
           of intubation

        4. New or increased vasopressor receipt between induction and 2 minutes after completion of
           intubation

      The secondary outcome is 28-day in-hospital mortality
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Cardiovascular collapse
time frame: 1 hour
description: A composite endpoint defined as one or more of the following
New systolic blood pressure < 65 mmHg between induction and 2 minutes after intubation
New or increased vasopressor between induction and 2 minutes after intubation
Cardiac arrest within 1 hour of intubation
Death within 1 hour of intubation
measure: 28-day in-hospital mortality
time frame: 28 days
measure: New systolic blood pressure < 65 mmHg between induction and 2 minutes after intubation
time frame: from induction to 2 minutes following tracheal intubation
measure: New or increased vasopressor between induction and 2 minutes after intubation
time frame: from induction to 2 minutes following tracheal intubation
measure: Cardiac arrest within 1 hour of intubation
time frame: 1 hour
measure: Death within 1 hour of intubation
time frame: 1 hour
measure: Lowest systolic blood pressure between induction and 2 minutes after intubation
time frame: from induction to 2 minutes following tracheal intubation
measure: Change in systolic blood pressure from induction to lowest systolic blood pressure
time frame: between induction and 2 minutes following procedure
measure: Ventilator-free days
time frame: 28 days
measure: ICU-free days
time frame: 28 days
measure: Lowest oxygen saturation
time frame: from induction to 2 minutes following tracheal intubation
description: Lowest arterial oxygen saturation between induction and 2 minutes after intubation
measure: Incidence of hypoxemia
time frame: from induction to 2 minutes following tracheal intubation
description: Incidence of oxygen saturation < 90% between induction and 2 minutes after intubation
measure: Incidence of severe hypoxemia
time frame: from induction to 2 minutes following tracheal intubation
description: Incidence of oxygen saturation < 80% between induction and 2 minutes after intubation
measure: Oxygen saturation at 24 hours after intubation
time frame: 24 hours
measure: Fraction of inspired oxygen at 24 hours after intubation
time frame: 24 hours
measure: Positive end expiratory pressure at 24 hours after intubation
time frame: 24 hours
measure: Systolic blood pressure at 24 hours after intubation
time frame: 24 hours
measure: Additional intravenous fluids initiated between induction and 2 minutes after intubation
time frame: from induction to 2 minutes following tracheal intubation
measure: Time from induction to successful intubation
time frame: Duration of procedure (minutes)
measure: Cormack-Lehane grade of glottic view on first attempt
time frame: Duration of procedure (minutes)
measure: Difficulty of intubation
time frame: Duration of procedure (minutes)
description: Operator-reported difficulty of intubation on a three-point ordinal scale of: easy, moderate, or difficult.
measure: Incidence of successful intubation on the first laryngoscopy attempt
time frame: Duration of procedure (minutes)
measure: Number of laryngoscopy attempts
time frame: Duration of procedure (minutes)
measure: Need for additional airway equipment or a second operator
time frame: Duration of procedure (minutes)
arm group label: Fluid Bolus
arm group type: Active Comparator
description: For patients randomized to fluid bolus administration, the bedside nurse will obtain 500 mL of a crystalloid solution of the operator's choosing, connect this volume to intravenous infusion tubing, and attach the tubing to any intravenous catheter or intraosseous device. The crystalloid solution will then be placed above the level of the intravenous or intraosseous device and allowed to infuse by gravity or pressure bag. At any time after the initiation of fluid bolus administration, the operator can choose to begin the procedure by administering sedation. Fluid loading will continue until all 500 mL are infused. Fluid infusing prior to the decision to perform endotracheal intubation will not be altered by the current study.
arm group label: No Fluid Bolus
arm group type: Active Comparator
description: For patients randomized to no fluid bolus administration, no additional intravenous crystalloid administration will be initiated between randomization and two minutes after completion of endotracheal intubation. Fluid infusing prior to the decision to perform endotracheal intubation will not be affected by the study. Treating clinicians may initiate a fluid bolus at any time for the treatment of cardiovascular collapse (not considered a protocol violation). Treating clinicians may also initiate a fluid bolus at any time if felt to be mandatory for the safe treatment of the patient (if between randomization and two minutes after intubation and in the absence of cardiovascular collapse this will be recorded as a protocol violation).
intervention type: Drug
intervention name: Fluid Bolus
description: 500 milliliters of an intravenous crystalloid solution of the operator's choosing
arm group label: Fluid Bolus
other name: intravenous crystalloid fluid, 500 mL
intervention type: Other
intervention name: No Fluid Bolus
description: No additional intravenous crystalloid administration initiated between randomization and two minutes after completion of endotracheal intubation
arm group label: No Fluid Bolus
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David R Janz, MD, MSCI
role: Principal Investigator
affiliation: Louisiana State University Health Sciences Center in New Orleans
last name: Derek W Russell, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Matthew Semler
investigator title: Assistant Professor of Medicine
mesh term: Respiratory Insufficiency
mesh term: Hypotension
mesh term: Shock
sharing ipd: Undecided