<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/NCT02188602</url>
  </required_header>
  <id_info>
    <org_study_id>27752</org_study_id>
    <nct_id>NCT02188602</nct_id>
  </id_info>
  <brief_title>Effect of Cumulative Chloride Dose on Development of Acute Kidney Injury in Critically Ill Children</brief_title>
  <official_title>Retrospective Investigation of Chloride Dosing and Its Effect on Acute Kidney Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators would like to investigate the effect of chloride dosing on the development&#xD;
      of acute kidney injury in critically ill patients. The investigators hypothesis is that&#xD;
      administering intravenous fluids with higher chloride content are more likely to lead to&#xD;
      acute kidney injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retrospective chart review from 2008-2012 evaluating chloride dosing and serum chloride&#xD;
      levels and their effects on acute kidney injury in the pediatric ICU. Patients will be&#xD;
      included for the first seven days of their PICU stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Researcher left institution&#xD;
  </why_stopped>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acute Kidney Injury</measure>
    <time_frame>7 days</time_frame>
    <description>or sooner if death or discharged</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PICU length of stay</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ventilator days</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>High Chloride Dose</arm_group_label>
    <description>Patients receiving high dosing of chloride</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Chloride Dose</arm_group_label>
    <description>Patients receiving low dosing of chloride</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children &lt; 18 yo admitted to the Pediatric Intensive Care Unit at Lucile Packard Children's&#xD;
        Hospital with admitting diagnosis of sepsis, respiratory failure, or liver failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age less than 18 years&#xD;
&#xD;
          -  PICU admitting diagnosis of sepsis, respiratory failure, or hepatic failure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hyponatremia or hypernatremia at PICU admission&#xD;
&#xD;
          -  preexisting diagnosis of End-stage renal disease or renal transplant&#xD;
&#xD;
          -  presence of neurologic comorbidities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weiwen V Shih, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lucile Packard Children's Hospital</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 19, 2013</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02188602
org study id: 27752
nct id: NCT02188602
lead sponsor: 
has dmc: Yes
The investigators would like to investigate the effect of chloride dosing on the development
      of acute kidney injury in critically ill patients. The investigators hypothesis is that
      administering intravenous fluids with higher chloride content are more likely to lead to
      acute kidney injury.
Retrospective chart review from 2008-2012 evaluating chloride dosing and serum chloride
      levels and their effects on acute kidney injury in the pediatric ICU. Patients will be
      included for the first seven days of their PICU stay.
observational model: Cohort
time perspective: Retrospective
measure: Acute Kidney Injury
time frame: 7 days
description: or sooner if death or discharged
measure: PICU length of stay
time frame: 7 days
measure: Hospital length of stay
time frame: 7 days
measure: Number of ventilator days
time frame: 7 days
measure: Mortality
time frame: 7 days
arm group label: High Chloride Dose
description: Patients receiving high dosing of chloride
arm group label: Low Chloride Dose
description: Patients receiving low dosing of chloride
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: No
last name: Weiwen V Shih, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries