<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/NCT03807648</url>
  </required_header>
  <id_info>
    <org_study_id>1050984</org_study_id>
    <nct_id>NCT03807648</nct_id>
  </id_info>
  <brief_title>I USE LR in the ED</brief_title>
  <official_title>Intermountain Utah Study Evaluating the Implementation of Lactated Ringers as Standard Resuscitation Fluid Starting in Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intermountain Health Care, Inc.</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>
      To study the difference in mortality and major adverse kidney events during and after&#xD;
      treatment in the emergency department with intravenous fluids per standard of care at 30 days&#xD;
      before and after the system-wide implementation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with major Adverse Kidney Events</measure>
    <time_frame>within 30 days or at hospital discharge</time_frame>
    <description>death from any cause, new renal replacement therapy or persistent renal dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>LR IV Fluids administered</measure>
    <time_frame>Through study completion (an average of 1 year)</time_frame>
    <description>Proportion of LR IV fluids following implementation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of hospital admission and readmission</measure>
    <time_frame>Within 30 days of initial ED encounter</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost</measure>
    <time_frame>Through study completion (an average of 1 year)</time_frame>
    <description>Direct costs of ED care and hospitalization</description>
  </secondary_outcome>
  <enrollment type="Actual">200000</enrollment>
  <condition>Kidney Injury</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data Inclusion</intervention_name>
    <description>Patients in this group will be included in the project</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Data to determine study outcomes will be extracted from the EDW and stored in a secure&#xD;
        database. No actualy contact with patients will take place for this data-only study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (≥18 years) receiving a minimum of 1000ml of intravenous fluids&#xD;
             starting in the emergency department per standard of care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≤17 years&#xD;
&#xD;
          -  Previously enrolled patients with &gt;1 ED admission within the 30-day follow-up period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84157-7000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>February 10, 2020</last_update_submitted>
  <last_update_submitted_qc>February 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03807648
org study id: 1050984
nct id: NCT03807648
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To study the difference in mortality and major adverse kidney events during and after
      treatment in the emergency department with intravenous fluids per standard of care at 30 days
      before and after the system-wide implementation.
observational model: Case-Control
time perspective: Prospective
measure: Number of participants with major Adverse Kidney Events
time frame: within 30 days or at hospital discharge
description: death from any cause, new renal replacement therapy or persistent renal dysfunction
measure: LR IV Fluids administered
time frame: Through study completion (an average of 1 year)
description: Proportion of LR IV fluids following implementation
measure: Rate of hospital admission and readmission
time frame: Within 30 days of initial ED encounter
measure: Cost
time frame: Through study completion (an average of 1 year)
description: Direct costs of ED care and hospitalization
intervention type: Other
intervention name: Data Inclusion
description: Patients in this group will be included in the project
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No