<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/NCT03787537</url>
  </required_header>
  <id_info>
    <org_study_id>EA2/094/17</org_study_id>
    <nct_id>NCT03787537</nct_id>
  </id_info>
  <brief_title>Nutritional Status and Nutrient Supply in Hospitalised Surgical Patients</brief_title>
  <official_title>Assessing Nutritional Status and Nutrient Supply in Hospitalised Patients Undergoing Major Abdominal Surgery of the Gastrointestinal Tract</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</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>
      Prospective single arm, single center observational study to assess the nutritional status&#xD;
      and the nutrient supply during hospitalization for elective gastrointestinal surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in nutritional status</measure>
    <time_frame>24 hours pre-surgery and 7 days after surgery</time_frame>
    <description>Controlling Nutritional Status (CONUT) score will be assessed at baseline and on postoperative day 7</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Energy intake</measure>
    <time_frame>1 day before surgery, the day of surgery and up to 7 days after surgery</time_frame>
    <description>Dietary intakes are collected by Food Frequency questionnaires and the data are expressed as the kilocalories (kcal) consumed per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma amino acid levels</measure>
    <time_frame>24 hours pre-surgery up to 7 days after surgery</time_frame>
    <description>Blood sample analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in beta-hydroxybutyrate levels</measure>
    <time_frame>24 hours pre-surgery up to 7 days after surgery</time_frame>
    <description>Blood sample analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in free fatty acid levels</measure>
    <time_frame>24 hours pre-surgery up to 7 days after surgery</time_frame>
    <description>Blood sample analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in triacylglycerides levels</measure>
    <time_frame>24 hours pre-surgery up to 7 days after surgery</time_frame>
    <description>Blood sample analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in low density lipoprotein levels</measure>
    <time_frame>24 hours pre-surgery up to 7 days after surgery</time_frame>
    <description>Blood sample analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">128</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Esophageal Cancer</condition>
  <condition>Gastric Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Elective surgical patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing elective surgery of the upper or lower gastrointestinal tract&#xD;
&#xD;
          -  mental and verbal ability to understand, read and write in German language&#xD;
&#xD;
          -  written informed consent for study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 years&#xD;
&#xD;
          -  inadequate ability to be compliant with the study protocol or to complete&#xD;
             documentation for the Food frequency questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Dr. Felix Aigner</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Nutrition</keyword>
  <keyword>Surgery</keyword>
  <!-- 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/NCT03787537
org study id: EA2/094/17
nct id: NCT03787537
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective single arm, single center observational study to assess the nutritional status
      and the nutrient supply during hospitalization for elective gastrointestinal surgery.
observational model: Cohort
time perspective: Prospective
measure: Change in nutritional status
time frame: 24 hours pre-surgery and 7 days after surgery
description: Controlling Nutritional Status (CONUT) score will be assessed at baseline and on postoperative day 7
measure: Energy intake
time frame: 1 day before surgery, the day of surgery and up to 7 days after surgery
description: Dietary intakes are collected by Food Frequency questionnaires and the data are expressed as the kilocalories (kcal) consumed per day
measure: Change in plasma amino acid levels
time frame: 24 hours pre-surgery up to 7 days after surgery
description: Blood sample analysis
measure: Change in beta-hydroxybutyrate levels
time frame: 24 hours pre-surgery up to 7 days after surgery
description: Blood sample analysis
measure: Change in free fatty acid levels
time frame: 24 hours pre-surgery up to 7 days after surgery
description: Blood sample analysis
measure: Change in triacylglycerides levels
time frame: 24 hours pre-surgery up to 7 days after surgery
description: Blood sample analysis
measure: Change in low density lipoprotein levels
time frame: 24 hours pre-surgery up to 7 days after surgery
description: Blood sample analysis
measure: length of hospital stay
time frame: 14 days
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Dr. Felix Aigner
investigator title: Principal Investigator