<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/NCT03813563</url>
  </required_header>
  <id_info>
    <org_study_id>RL vs Plalyte</org_study_id>
    <nct_id>NCT03813563</nct_id>
  </id_info>
  <brief_title>Lactated Ringer's and PlasmaLyte in Critically Ill Adults</brief_title>
  <official_title>Lactated Ringer's and PlasmaLyte in Critically Ill Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</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>
      In recent years, there has been a large amount of literature reports that normal saline can&#xD;
      increase the incidence of renal injury in critically ill patients compared with balanced salt&#xD;
      solution.However, no studies have compared the effects of different types of balanced salt&#xD;
      solutions on the incidence of renal injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 13, 2018</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 2018</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>The incidence of acute kidney injury</measure>
    <time_frame>from admission to 28 days</time_frame>
    <description>The incidence of acute kidney injury</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the incidency of CRRT events</measure>
    <time_frame>from admission to 28 days</time_frame>
    <description>the incidency of CRRT events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the ventilation free days</measure>
    <time_frame>from admission to 28 days</time_frame>
    <description>the ventilation free days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the vasopressure free days</measure>
    <time_frame>from admission to 28 days</time_frame>
    <description>the vasopressure free days</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">12000</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Mix group</arm_group_label>
    <description>Patients who used two balanced salt solutions during icu stay</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RL group</arm_group_label>
    <description>Patients who have only used lactated Ringer's during icu stay</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLA group</arm_group_label>
    <description>Patients who have only used PlasmaLyte during icu stay</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RL</intervention_name>
    <description>lactated Ringer's</description>
    <arm_group_label>Mix group</arm_group_label>
    <arm_group_label>RL group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PLA</intervention_name>
    <description>PlasmaLyte</description>
    <arm_group_label>Mix group</arm_group_label>
    <arm_group_label>PLA group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All ICU admissions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted to ICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt;18 year old when admission&#xD;
&#xD;
          -  Patients who stay less than 24 hours in ICU&#xD;
&#xD;
          -  Patients who do not sufficient data for further analysis&#xD;
&#xD;
          -  Readmission patients during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Critical care medicine of West China Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Kang Yan</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT03813563
org study id: RL vs Plalyte
nct id: NCT03813563
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In recent years, there has been a large amount of literature reports that normal saline can
      increase the incidence of renal injury in critically ill patients compared with balanced salt
      solution.However, no studies have compared the effects of different types of balanced salt
      solutions on the incidence of renal injury.
observational model: Cohort
time perspective: Retrospective
measure: The incidence of acute kidney injury
time frame: from admission to 28 days
description: The incidence of acute kidney injury
measure: the incidency of CRRT events
time frame: from admission to 28 days
description: the incidency of CRRT events
measure: the ventilation free days
time frame: from admission to 28 days
description: the ventilation free days
measure: the vasopressure free days
time frame: from admission to 28 days
description: the vasopressure free days
arm group label: Mix group
description: Patients who used two balanced salt solutions during icu stay
arm group label: RL group
description: Patients who have only used lactated Ringer's during icu stay
arm group label: PLA group
description: Patients who have only used PlasmaLyte during icu stay
intervention type: Drug
intervention name: RL
description: lactated Ringer's
arm group label: Mix group
arm group label: RL group
intervention type: Drug
intervention name: PLA
description: PlasmaLyte
arm group label: Mix group
arm group label: PLA group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: West China Hospital
investigator full name: Kang Yan
investigator title: Clinical Professor
mesh term: Critical Illness
sharing ipd: Undecided