<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/NCT04449796</url>
  </required_header>
  <id_info>
    <org_study_id>nWMO 2018-312</org_study_id>
    <nct_id>NCT04449796</nct_id>
  </id_info>
  <brief_title>Predictive Value of Bio-impedance Vector Analysis on Long-term Outcome in ICU Patients</brief_title>
  <official_title>Predictive Value of Bio-impedance Vector Analysis on Long-term Outcome in ICU Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical Centre Leeuwarden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical Centre Leeuwarden</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>
      Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity&#xD;
      in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a&#xD;
      measure of body composition, changes with the physical condition of patients and is&#xD;
      associated with survival in several disease states and during ICU admission. Aim of the study&#xD;
      is to explore the predictive value of the phase angle for long term ICU outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity&#xD;
      in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a&#xD;
      measure of body composition, changes with the physical condition of patients and is&#xD;
      associated with survival in several disease states and during ICU admission. Aim of the study&#xD;
      is to explore the predictive value of the phase angle for long term ICU survival.&#xD;
&#xD;
      A single-centre prospective observational cohort will be performed with consecutive patients,&#xD;
      elective and non elective, admitted to the ICU between 1st June 2018 and 1st June 2019.&#xD;
      Demographic data, APACHE III, comorbidity and phase angle are collected and the ICU- ,&#xD;
      hospital- and 6 months survival will be registered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>3 months survival</measure>
    <time_frame>3 months</time_frame>
    <description>100% minus all-cause mortality at three month post ICU</description>
  </primary_outcome>
  <primary_outcome>
    <measure>6 months survival</measure>
    <time_frame>6 months</time_frame>
    <description>100% minus all-cause mortality at six month post ICU</description>
  </primary_outcome>
  <primary_outcome>
    <measure>12 months survival</measure>
    <time_frame>12 months</time_frame>
    <description>100% minus all-cause mortalityat twelve month post ICU</description>
  </primary_outcome>
  <enrollment type="Actual">1025</enrollment>
  <condition>Long-term Outcome</condition>
  <condition>Survival</condition>
  <eligibility>
    <study_pop>
      <textblock>
        all patiens admitted to the ICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients admitted to the ICU, elective and acute.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age below 18&#xD;
&#xD;
          -  Length of stay at ICU &lt; 6 hours&#xD;
&#xD;
          -  All invalid bio-impedence analysis (BIA) measurements&#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>E.C. Boerma, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Centre Leeuwarden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Centre Leeuwarden - Intensive Care Unit</name>
      <address>
        <city>Leeuwarden</city>
        <zip>8901 BR</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 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/NCT04449796
org study id: nWMO 2018-312
nct id: NCT04449796
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity
      in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a
      measure of body composition, changes with the physical condition of patients and is
      associated with survival in several disease states and during ICU admission. Aim of the study
      is to explore the predictive value of the phase angle for long term ICU outcome.
Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity
      in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a
      measure of body composition, changes with the physical condition of patients and is
      associated with survival in several disease states and during ICU admission. Aim of the study
      is to explore the predictive value of the phase angle for long term ICU survival.

      A single-centre prospective observational cohort will be performed with consecutive patients,
      elective and non elective, admitted to the ICU between 1st June 2018 and 1st June 2019.
      Demographic data, APACHE III, comorbidity and phase angle are collected and the ICU- ,
      hospital- and 6 months survival will be registered.
observational model: Cohort
time perspective: Prospective
measure: 3 months survival
time frame: 3 months
description: 100% minus all-cause mortality at three month post ICU
measure: 6 months survival
time frame: 6 months
description: 100% minus all-cause mortality at six month post ICU
measure: 12 months survival
time frame: 12 months
description: 100% minus all-cause mortalityat twelve month post ICU
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: E.C. Boerma, MD PhD
role: Principal Investigator
affiliation: Medical Centre Leeuwarden
facility: 
country: Netherlands
responsible party type: Sponsor
sharing ipd: No