<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/NCT01680770</url>
  </required_header>
  <id_info>
    <org_study_id>10-566B</org_study_id>
    <nct_id>NCT01680770</nct_id>
  </id_info>
  <brief_title>Use of Ultrasonography to Determine Fluid-responsiveness for Shock in a Population of Intensive Care Unit Patients</brief_title>
  <official_title>Use of Ultrasonography to Determine Fluid-responsiveness for Shock in a Population of Intensive Care Unit Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of our study is to determine the correlation of transthoracic ultrasonographic&#xD;
      indices of fluid responsiveness to changes in direct measures of cardiac output and to&#xD;
      compare them to other established predictors of fluid responsiveness such as central venous&#xD;
      pressure variation, systolic arterial pressure variation and pulse pressure variation in a&#xD;
      broad population of patients.&#xD;
&#xD;
      Hypothesis: There will be a significant difference in the inferior vena cava respiratory&#xD;
      variation and subclavian vein respiratory variation between responders and non-responders to&#xD;
      intravenous fluid challenge in a broad population of patients with shock.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shock is a common occurrence in the intensive care unit (ICU), and the management of this&#xD;
      condition frequently requires the administration of intravenous fluids (IVF). Multiple&#xD;
      studies have shown that only about 50% of these patients will respond to fluids. The ability&#xD;
      to predict which patients will respond is an important tool for clinicians to treat shock&#xD;
      while avoiding unnecessary fluid administration in those who are unlikely to respond. This is&#xD;
      essential to avoid the adverse effects of fluid loading that can occur.&#xD;
&#xD;
      A number of studies have attempted to determine predictors of volume-responsiveness through&#xD;
      various methods, including the use of ultrasonography performed by intensivists,&#xD;
      anesthesiologists and emergency medicine physicians. The currently published studies&#xD;
      establish predictors of fluid-responsiveness in their populations. However, there has been&#xD;
      large variability in the study designs, making it difficult to compare different modalities.&#xD;
&#xD;
      The objective of our study is to determine the correlation of transthoracic ultrasonographic&#xD;
      indices of fluid responsiveness to changes in direct measures of cardiac output and to&#xD;
      compare them to other established predictors of fluid responsiveness such as central venous&#xD;
      pressure variation, systolic arterial pressure variation and pulse pressure variation.&#xD;
      Furthermore, we wish to include a broad range of patients with different types of shock in&#xD;
      order to determine the generalized applicability of these indices. Additionally, reported&#xD;
      success of intensivist-obtained echocardiographic images varies widely in the literature, but&#xD;
      most studies do not report which views are most accessible. We plan to study prospectively&#xD;
      which views are obtainable and correlate them to patient characteristics.&#xD;
&#xD;
      This would potentially establish echocardiography by an intensivist as a widely applicable,&#xD;
      non-invasive, and easily accessible method for determining fluid-responsiveness in a patient&#xD;
      with shock. Achievement of this goal would allow clinicians to quickly identify those&#xD;
      patients that would respond to fluids and at the same time minimize the administration of&#xD;
      fluids to those in whom it is unlikely to benefit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fluid Responder vs. Non-responder</measure>
    <time_frame>pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)</time_frame>
    <description>Patients will be divided into responder and non-responder groups based on an increase in cardiac output of greater than or equal to 15% as measured by thermodilution from a right heart catheter in response to a one liter normal saline fluid bolus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inferior vena cava diameter and respiratory variation</measure>
    <time_frame>pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)</time_frame>
    <description>pre-fluid Inferior vena cava diameter and Inferior vena cava respiratory variations will be correlated to fluid responsiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>subclavian vein diameter and respiratory variation</measure>
    <time_frame>pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)</time_frame>
    <description>pre-fluid subclavian diameter and subclavian respiratory variations will be correlated to fluid responsiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulse pressure variation</measure>
    <time_frame>pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)</time_frame>
    <description>pre-fluid pulse pressure variation will be correlated to fluid responsiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>central venous pressure (CVP) and CVP respiratory variation</measure>
    <time_frame>pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)</time_frame>
    <description>pre-fluid CVP and CVP respiratory variations will be correlated to fluid responsiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulmonary capillary wedge pressure (PCWP) and respiratory variations of PCWP</measure>
    <time_frame>pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)</time_frame>
    <description>pre-fluid PCWP and PCWP respiratory variations will be correlated to fluid responsiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Possible views of echocardiogram</measure>
    <time_frame>pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)</time_frame>
    <description>Determine percentage of which echocardiographic views are obtainable in a broad population of patients with shock and correlate to patient characteristics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concurrence with cardiologist interpretation</measure>
    <time_frame>pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)</time_frame>
    <description>Determine the rate at which cardiologist concurs with intensivist interpretation of echocardiographic images.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Hypotension</condition>
  <arm_group>
    <arm_group_label>Hypotensive patients in shock</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Intensive Care Unit Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients (&gt; 18 years old) admitted to the intensive care unit.&#xD;
&#xD;
          2. Decision by clinicians to give intravenous fluids for volume expansion.&#xD;
&#xD;
          3. Decision by clinicians to obtain central venous access.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with known chronic right heart failure syndromes.&#xD;
&#xD;
          2. Patients with terminal conditions in whom aggressive care will not be pursued.&#xD;
&#xD;
          3. Patients with a history of left bundle branch block.&#xD;
&#xD;
          4. Patients will not be excluded on the basis of sex, race, or ethnicity.&#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>Kress P John, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>July 22, 2022</last_update_submitted>
  <last_update_submitted_qc>July 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>shock</keyword>
  <keyword>transthoracic echocardiography</keyword>
  <keyword>critical care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01680770
org study id: 10-566B
nct id: NCT01680770
lead sponsor: 
has dmc: Yes
The objective of our study is to determine the correlation of transthoracic ultrasonographic
      indices of fluid responsiveness to changes in direct measures of cardiac output and to
      compare them to other established predictors of fluid responsiveness such as central venous
      pressure variation, systolic arterial pressure variation and pulse pressure variation in a
      broad population of patients.

      Hypothesis: There will be a significant difference in the inferior vena cava respiratory
      variation and subclavian vein respiratory variation between responders and non-responders to
      intravenous fluid challenge in a broad population of patients with shock.
Shock is a common occurrence in the intensive care unit (ICU), and the management of this
      condition frequently requires the administration of intravenous fluids (IVF). Multiple
      studies have shown that only about 50% of these patients will respond to fluids. The ability
      to predict which patients will respond is an important tool for clinicians to treat shock
      while avoiding unnecessary fluid administration in those who are unlikely to respond. This is
      essential to avoid the adverse effects of fluid loading that can occur.

      A number of studies have attempted to determine predictors of volume-responsiveness through
      various methods, including the use of ultrasonography performed by intensivists,
      anesthesiologists and emergency medicine physicians. The currently published studies
      establish predictors of fluid-responsiveness in their populations. However, there has been
      large variability in the study designs, making it difficult to compare different modalities.

      The objective of our study is to determine the correlation of transthoracic ultrasonographic
      indices of fluid responsiveness to changes in direct measures of cardiac output and to
      compare them to other established predictors of fluid responsiveness such as central venous
      pressure variation, systolic arterial pressure variation and pulse pressure variation.
      Furthermore, we wish to include a broad range of patients with different types of shock in
      order to determine the generalized applicability of these indices. Additionally, reported
      success of intensivist-obtained echocardiographic images varies widely in the literature, but
      most studies do not report which views are most accessible. We plan to study prospectively
      which views are obtainable and correlate them to patient characteristics.

      This would potentially establish echocardiography by an intensivist as a widely applicable,
      non-invasive, and easily accessible method for determining fluid-responsiveness in a patient
      with shock. Achievement of this goal would allow clinicians to quickly identify those
      patients that would respond to fluids and at the same time minimize the administration of
      fluids to those in whom it is unlikely to benefit.
observational model: Cohort
time perspective: Prospective
measure: Fluid Responder vs. Non-responder
time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
description: Patients will be divided into responder and non-responder groups based on an increase in cardiac output of greater than or equal to 15% as measured by thermodilution from a right heart catheter in response to a one liter normal saline fluid bolus.
measure: Inferior vena cava diameter and respiratory variation
time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
description: pre-fluid Inferior vena cava diameter and Inferior vena cava respiratory variations will be correlated to fluid responsiveness
measure: subclavian vein diameter and respiratory variation
time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
description: pre-fluid subclavian diameter and subclavian respiratory variations will be correlated to fluid responsiveness
measure: pulse pressure variation
time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
description: pre-fluid pulse pressure variation will be correlated to fluid responsiveness
measure: central venous pressure (CVP) and CVP respiratory variation
time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
description: pre-fluid CVP and CVP respiratory variations will be correlated to fluid responsiveness
measure: pulmonary capillary wedge pressure (PCWP) and respiratory variations of PCWP
time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
description: pre-fluid PCWP and PCWP respiratory variations will be correlated to fluid responsiveness
measure: Possible views of echocardiogram
time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
description: Determine percentage of which echocardiographic views are obtainable in a broad population of patients with shock and correlate to patient characteristics
measure: Concurrence with cardiologist interpretation
time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
description: Determine the rate at which cardiologist concurs with intensivist interpretation of echocardiographic images.
arm group label: Hypotensive patients in shock
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kress P John, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypotension
sharing ipd: No