xml: <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/NCT05967858</url>
    </required_header>
    <id_info>
      <org_study_id>norge refeed</org_study_id>
      <nct_id>NCT05967858</nct_id>
    </id_info>
    <brief_title>Incidence of Refeeding Syndrome in Consecutively Admitted Patients</brief_title>
    <official_title>Refeeding Syndrome - Incidence and Risk Factors: An Observational Study on Patients With G-I Disease and Head-neck Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jens Rikardt Andersen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>St. Olavs Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Copenhagen</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>
        The incidence and main risk-factors analyzed in consecutive in-patients in the departments og&#xD;
        gastroenterology and ear-nose and throat diseases (cancer in radiation therapy)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with either parenteral- or tube feeding enter the study to assure sufficient&#xD;
        nutrition.&#xD;
  &#xD;
        During hospitalization patients were monitored with daily blood samples and clinical&#xD;
        evaluation of symptoms in addition to the coverage of energy and protein in percent of&#xD;
        estimated needs.&#xD;
  &#xD;
        Refeeding phenomenon was defined as a decrease in plasma phosphate after the initiation of&#xD;
        nutrition.&#xD;
  &#xD;
        Refeeding syndrome as refeeding phenomenon and one or more relevant symptoms in addition&#xD;
        (hypotension, cardiac arrhythmia, edema, confusion)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2013</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">May 31, 2014</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>Refeeding syndrome</measure>
      <time_frame>1 week after start of nutrition</time_frame>
      <description>No. patients with decrease in plasma phosphate + clinical symptoms</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Refeeding phenomenon</measure>
      <time_frame>1 week after start of nutrition</time_frame>
      <description>No. patients with decrease in plasma phosphate after start of nutrition</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">51</enrollment>
    <condition>Refeeding Syndrome</condition>
    <condition>Starvation</condition>
    <condition>Phosphate Deficiency</condition>
    <arm_group>
      <arm_group_label>gastroenterological</arm_group_label>
      <description>Consecutive admissions - n= 43 - 34 operated (79%) - 10 patients acutely admitted Diseases in Esophagus (8), gastric cavity (8), pancreas (7), colon/rectum (8), bile (4), small intestine (3), IBD (5) No interventions in the treatments, just observation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>head and neck cancer</arm_group_label>
      <description>Consecutive admissions - n=8 - 7 radiation therapy - 1 operated Locations: 2 Larynx, 1 oro-pharynx, 4 tonsillar, 1 tung No interventions in the treatments, just observation</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>observation</intervention_name>
      <description>no intervention</description>
      <arm_group_label>gastroenterological</arm_group_label>
      <arm_group_label>head and neck cancer</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          No other than willingness to participate and consecutively admitted, as well as planned&#xD;
          sufficient nutrition&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  planned tube- or parenteral nutrition (complete or supplementary)&#xD;
  &#xD;
            -  &gt; 18 years&#xD;
  &#xD;
            -  written consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Renal insufficiency (p-creatinine &gt;200 micromol/l)&#xD;
  &#xD;
            -  Lack of ability to communicate (registration of nutritional intake etc)&#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>jens R Andersen, MD, MPA</last_name>
      <role>Study Chair</role>
      <affiliation>University of Copenhagen</affiliation>
    </overall_official>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Copenhagen</investigator_affiliation>
      <investigator_full_name>Jens Rikardt Andersen</investigator_full_name>
      <investigator_title>Assoc Prof</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Refeeding Syndrome</mesh_term>
      <mesh_term>Starvation</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967858
  org study id: norge refeed
  nct id: NCT05967858
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The incidence and main risk-factors analyzed in consecutive in-patients in the departments og
        gastroenterology and ear-nose and throat diseases (cancer in radiation therapy)
  Patients with either parenteral- or tube feeding enter the study to assure sufficient
        nutrition.
  
        During hospitalization patients were monitored with daily blood samples and clinical
        evaluation of symptoms in addition to the coverage of energy and protein in percent of
        estimated needs.
  
        Refeeding phenomenon was defined as a decrease in plasma phosphate after the initiation of
        nutrition.
  
        Refeeding syndrome as refeeding phenomenon and one or more relevant symptoms in addition
        (hypotension, cardiac arrhythmia, edema, confusion)
  observational model: Cohort
  time perspective: Prospective
  measure: Refeeding syndrome
  time frame: 1 week after start of nutrition
  description: No. patients with decrease in plasma phosphate + clinical symptoms
  measure: Refeeding phenomenon
  time frame: 1 week after start of nutrition
  description: No. patients with decrease in plasma phosphate after start of nutrition
  arm group label: gastroenterological
  description: Consecutive admissions - n= 43 - 34 operated (79%) - 10 patients acutely admitted Diseases in Esophagus (8), gastric cavity (8), pancreas (7), colon/rectum (8), bile (4), small intestine (3), IBD (5) No interventions in the treatments, just observation
  arm group label: head and neck cancer
  description: Consecutive admissions - n=8 - 7 radiation therapy - 1 operated Locations: 2 Larynx, 1 oro-pharynx, 4 tonsillar, 1 tung No interventions in the treatments, just observation
  intervention type: Other
  intervention name: observation
  description: no intervention
  arm group label: gastroenterological
  arm group label: head and neck cancer
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: jens R Andersen, MD, MPA
  role: Study Chair
  affiliation: University of Copenhagen
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Copenhagen
  investigator full name: Jens Rikardt Andersen
  investigator title: Assoc Prof
  mesh term: Refeeding Syndrome
  mesh term: Starvation
  mesh term: Syndrome
  sharing ipd: No