<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/NCT02189993</url>
  </required_header>
  <id_info>
    <org_study_id>TPN-01</org_study_id>
    <nct_id>NCT02189993</nct_id>
  </id_info>
  <brief_title>Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition</brief_title>
  <official_title>Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amsterdam UMC, location VUmc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine what the long term survival is after in hospital&#xD;
      use of total parenteral nutrition due to intestinal failure.&#xD;
&#xD;
      Earlier studies only followed patients for a maximum of 6 months or included only very&#xD;
      specific patients. We were interested in all patients in our hospital and followed them for&#xD;
      up to 2 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Extensive description is not desired&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">April 2012</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>All cause mortality</measure>
    <time_frame>Up to 1427 days</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">437</enrollment>
  <condition>Nutrition Disorders</condition>
  <arm_group>
    <arm_group_label>Total Parenteral Nutrition Use</arm_group_label>
    <description>The cohort investigated consisted of patients with intestinal failure requiring total parenteral nutrition use.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients requiring total parenteral nutrition during in hospital admission.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all consecutive patients on TPN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients from the Pediatric and Haematological Departments&#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>Leendert Oterdoom, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VUMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Gastroenterology and Hepatology, Small Bowel Unit, VU University Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Amsterdam UMC, location VUmc</investigator_affiliation>
    <investigator_full_name>Leendert Oterdoom</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Mortality</keyword>
  <keyword>Long term follow-up</keyword>
  <keyword>Parenteral Nutrition, Total</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Failure</mesh_term>
    <mesh_term>Nutrition Disorders</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/NCT02189993
org study id: TPN-01
nct id: NCT02189993
lead sponsor: 
has dmc: No
The purpose of this study is to determine what the long term survival is after in hospital
      use of total parenteral nutrition due to intestinal failure.

      Earlier studies only followed patients for a maximum of 6 months or included only very
      specific patients. We were interested in all patients in our hospital and followed them for
      up to 2 years.
Extensive description is not desired
observational model: Cohort
time perspective: Retrospective
measure: All cause mortality
time frame: Up to 1427 days
arm group label: Total Parenteral Nutrition Use
description: The cohort investigated consisted of patients with intestinal failure requiring total parenteral nutrition use.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Leendert Oterdoom, MD PhD
role: Principal Investigator
affiliation: VUMC
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Amsterdam UMC, location VUmc
investigator full name: Leendert Oterdoom
investigator title: Dr.
mesh term: Intestinal Failure
mesh term: Nutrition Disorders