<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/NCT03814057</url>
  </required_header>
  <id_info>
    <org_study_id>AinShamsGer</org_study_id>
    <nct_id>NCT03814057</nct_id>
  </id_info>
  <brief_title>Creatinine Height Index in Elderly</brief_title>
  <official_title>Age- Adjusted Measurements of Creatinine Height Index for Diagnosing Malnutrition in Elderly Medical Patients at Hospital Admission</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      evaluation of the efficacy of two different age adjusted calculations of CHI compared to&#xD;
      other nutritional indicators in the elderly medical patients upon hospital admission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cross sectional study involving one hundred hospitalized elderly (&gt;60 years), Anthropometric&#xD;
      measurements, Mini- nutritional assessment, Hand Grip strength, CBC, total protein, albumin,&#xD;
      total cholesterol, triglyceride, and 24 hour urinary creatinine excretion were measured&#xD;
      within 24 hours of hospital admission calculation of CHI using 2 age adjusted modification&#xD;
      was done accuracy of each measurement in detecting malnutrition was evaluated&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2015</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>accuracy of creatinine height index in Elderly</measure>
    <time_frame>within 24 hours of hospital admission</time_frame>
    <description>evaluate the test performance of the two age adjusted calculations of creatinine height index for detecting malnutrition in elderly patients at hospital admission</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Malnutrition in Elderly</condition>
  <arm_group>
    <arm_group_label>Elderly Medical Patients at hospital admission</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>24 hour urine creatinine excretion</intervention_name>
    <description>two age corrected calculations of creatinine height index were obtained</description>
    <arm_group_label>Elderly Medical Patients at hospital admission</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Elderly Medical Patients at hospital admission with exclusion of factors might affect 24&#xD;
        hour urine collection or urinary creatinine excretion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medical elderly patients (&gt;60 years)&#xD;
&#xD;
          -  within 24 hours of hospital admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  sepsis&#xD;
&#xD;
          -  fever&#xD;
&#xD;
          -  malignancy&#xD;
&#xD;
          -  liver cirrhosis&#xD;
&#xD;
          -  renal impairment&#xD;
&#xD;
          -  critically ill patients&#xD;
&#xD;
          -  those with any hemodynamic instability were excluded from the study&#xD;
&#xD;
          -  patients receiving diuretics&#xD;
&#xD;
          -  patients can't stand to obtain their weight and height&#xD;
&#xD;
          -  those can't collect 24 hour urine&#xD;
&#xD;
          -  the patients refused to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>DOHA RASHEEDY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 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 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Doha Rasheedy</investigator_full_name>
    <investigator_title>Assistant Professor of Geriatric Medicine</investigator_title>
  </responsible_party>
  <keyword>Anthropometric measurements,</keyword>
  <keyword>creatinine height index</keyword>
  <keyword>lean body mass</keyword>
  <keyword>Mini- nutritional assessment</keyword>
  <keyword>Hand Grip strength</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</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/NCT03814057
org study id: AinShamsGer
nct id: NCT03814057
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
evaluation of the efficacy of two different age adjusted calculations of CHI compared to
      other nutritional indicators in the elderly medical patients upon hospital admission.
Cross sectional study involving one hundred hospitalized elderly (>60 years), Anthropometric
      measurements, Mini- nutritional assessment, Hand Grip strength, CBC, total protein, albumin,
      total cholesterol, triglyceride, and 24 hour urinary creatinine excretion were measured
      within 24 hours of hospital admission calculation of CHI using 2 age adjusted modification
      was done accuracy of each measurement in detecting malnutrition was evaluated
observational model: Cohort
time perspective: Cross-Sectional
measure: accuracy of creatinine height index in Elderly
time frame: within 24 hours of hospital admission
description: evaluate the test performance of the two age adjusted calculations of creatinine height index for detecting malnutrition in elderly patients at hospital admission
arm group label: Elderly Medical Patients at hospital admission
intervention type: Diagnostic Test
intervention name: 24 hour urine creatinine excretion
description: two age corrected calculations of creatinine height index were obtained
arm group label: Elderly Medical Patients at hospital admission
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: DOHA RASHEEDY, MD
role: Principal Investigator
affiliation: Ain Shams University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Doha Rasheedy
investigator title: Assistant Professor of Geriatric Medicine
mesh term: Malnutrition