<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/NCT04434079</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0486</org_study_id>
    <nct_id>NCT04434079</nct_id>
  </id_info>
  <brief_title>Fluid Balance and Body Weight Changes in Critically Ill Adult Patients</brief_title>
  <official_title>Fluid Balance and Body Weight Changes in Critically Ill Adult Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      Positive fluid status has been consistently associated with worse prognosis in critically ill&#xD;
      adult patients.However, observational studies showed poor agreement between fluid balance and&#xD;
      body weight changes. The objective of the study is to compare the measurements of FB and BW&#xD;
      over time and to assess correlation with ICU mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Positive fluid status has been consistently associated with worse prognosis in critically ill&#xD;
      adult patients. Daily and cumulative fluid balance (FB) is a routine nursing activity in&#xD;
      intensive care unit (ICU). In view of the potential for errors in the calculation of FB&#xD;
      totals and the problem of accounting for insensible fluid losses, measurement of body weight&#xD;
      (BW) changes is an alternative non-invasive method commonly used for estimating body fluid&#xD;
      status. Its accuracy over FB assumes a one kilogram change in BW equates to a one liter gain&#xD;
      or loss in body fluid volume. However, observational studies showed poor agreement between&#xD;
      those measurements, particularly among individuals staying more than a week in ICU possibly&#xD;
      due to muscle and fat loss as well as bone demineralization. The objective of the study is to&#xD;
      compare the measurements of FB and BW over time and to assess correlation with ICU mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight</measure>
    <time_frame>At midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first.</time_frame>
    <description>Correlation between daily fluid balance and weight change (Bland-Altman agreement test)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between cumulative fluid balance and total weight change</measure>
    <time_frame>Last day of each patient's ICU hospitalization, up to 6 months</time_frame>
    <description>Correlation between cumulative fluid balance and total weight change (Bland-Altman)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminative power of fluid balance in predicting ICU mortality</measure>
    <time_frame>Through study completion, up to 6 months</time_frame>
    <description>Area under ROC curve for fluid balance (L). ICU mortality as reference variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminative power of body weight changes in predicting ICU mortality</measure>
    <time_frame>Through study completion, up to 6 months</time_frame>
    <description>Area under ROC curve for body weight change (kg). ICU mortality as reference variable.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">98</enrollment>
  <condition>Critical Illness</condition>
  <condition>Fluid Overload</condition>
  <arm_group>
    <arm_group_label>Included individuals</arm_group_label>
    <description>Adult patients consecutively admitted to the ICU from June to October 2018 are eligible if expected length of stay is superior to 24 hours and no oral nutritional has been offered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regular critical care</intervention_name>
    <description>Clinical demographic data, daily and cumulative FB (input minus output) with and without insensible fluid losses, and daily and total BW changes are recorded, as well as survival outcome.</description>
    <arm_group_label>Included individuals</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients consecutively admitted to the ICU from June to October 2018 are eligible&#xD;
        if expected length of ICU stay is superior to 24 hours and no oral nutritional is being&#xD;
        offered.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals aged &gt;18 years-old admitted to ICU;&#xD;
&#xD;
          -  Expected length of ICU stay superior to 24 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals receiving oral diet;&#xD;
&#xD;
          -  Actual body weight superior to 227kgs or 501lb.&#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>Ana Carolina P Antonio, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fluid Balance</keyword>
  <keyword>Body Weight Change</keyword>
  <keyword>Critical Illness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Body Weight Changes</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/NCT04434079
org study id: 2018-0486
nct id: NCT04434079
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Positive fluid status has been consistently associated with worse prognosis in critically ill
      adult patients.However, observational studies showed poor agreement between fluid balance and
      body weight changes. The objective of the study is to compare the measurements of FB and BW
      over time and to assess correlation with ICU mortality.
Positive fluid status has been consistently associated with worse prognosis in critically ill
      adult patients. Daily and cumulative fluid balance (FB) is a routine nursing activity in
      intensive care unit (ICU). In view of the potential for errors in the calculation of FB
      totals and the problem of accounting for insensible fluid losses, measurement of body weight
      (BW) changes is an alternative non-invasive method commonly used for estimating body fluid
      status. Its accuracy over FB assumes a one kilogram change in BW equates to a one liter gain
      or loss in body fluid volume. However, observational studies showed poor agreement between
      those measurements, particularly among individuals staying more than a week in ICU possibly
      due to muscle and fat loss as well as bone demineralization. The objective of the study is to
      compare the measurements of FB and BW over time and to assess correlation with ICU mortality.
observational model: Case-Only
time perspective: Prospective
measure: Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight
time frame: At midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first.
description: Correlation between daily fluid balance and weight change (Bland-Altman agreement test)
measure: Correlation between cumulative fluid balance and total weight change
time frame: Last day of each patient's ICU hospitalization, up to 6 months
description: Correlation between cumulative fluid balance and total weight change (Bland-Altman)
measure: Discriminative power of fluid balance in predicting ICU mortality
time frame: Through study completion, up to 6 months
description: Area under ROC curve for fluid balance (L). ICU mortality as reference variable.
measure: Discriminative power of body weight changes in predicting ICU mortality
time frame: Through study completion, up to 6 months
description: Area under ROC curve for body weight change (kg). ICU mortality as reference variable.
arm group label: Included individuals
description: Adult patients consecutively admitted to the ICU from June to October 2018 are eligible if expected length of stay is superior to 24 hours and no oral nutritional has been offered.
intervention type: Other
intervention name: Regular critical care
description: Clinical demographic data, daily and cumulative FB (input minus output) with and without insensible fluid losses, and daily and total BW changes are recorded, as well as survival outcome.
arm group label: Included individuals
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ana Carolina P Antonio, MD, PhD
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Critical Illness
mesh term: Body Weight
mesh term: Body Weight Changes