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/NCT06023251</url>
    </required_header>
    <id_info>
      <org_study_id>EC-2023-236</org_study_id>
      <nct_id>NCT06023251</nct_id>
    </id_info>
    <brief_title>Improving Nutritional Adequacy of ICU Survivors in a Prospective Interventional Way: the Bright Side Study</brief_title>
    <acronym>BrightSide</acronym>
    <official_title>Does the Use of Supplemental Parenteral/Enteral Nutrition and/or Oral Nutrition Supplements Guided by Indirect Calorimetry Combined With Standard of Care Increases Energy Feeding Adequacy in Patients Who Survived Critical Illness?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitair Ziekenhuis Brussel</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitair Ziekenhuis Brussel</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>
        The objective is to increase caloric adequacy in patients who survived critical illness and&#xD;
        are admitted to the ward by the use of a pro-active inclusive nutritional strategy including&#xD;
        supplemental parenteral and/or enteral nutrition and/or oral nutritional supplements guided&#xD;
        by indirect calorimetry.&#xD;
  &#xD;
        This enables the investigators to address, within a clinical/scientific context, a recently&#xD;
        demonstrated but until now relatively neglected 'dark side' of patient care at UZ Brussel,&#xD;
        comparable to limited global evidence : iatrogenic malnutrition of ICU survivors. The use of&#xD;
        a newly developed clinical pathway and nutrition strategy (oral, enteral and parenteral) led&#xD;
        by a single SPoC (Single Point of Contact) for patients surviving intensive care will have a&#xD;
        clear objective: to address the nutritional deficit in all patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Nutrition Adequacy</measure>
      <time_frame>The adequacy will be calculated over the entire ward stay: from date of inclusion till 28 days later or death from any cause, whichever came first.</time_frame>
      <description>Increase of caloric adequacy (from 58 to 80%) and protein adequacy (from 52 to 80%) in ICU survivors</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Malnutrition</condition>
    <arm_group>
      <arm_group_label>Cohort</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>oral food, enteral nutrition, parenteral nutrition</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Clinical Nutrition</intervention_name>
      <description>Nutritional care plan implementation, including&#xD;
  A step-up and step-down nutritional protocol guided by caloric and protein ratio&#xD;
  Monitoring plan including daily nutritional intake assessment by a dietician and (para)medical supervision by a nutrition support pharmacist and nurse concerning dysphagia, refeeding syndrome, electrolytes abnormalities and access issues&#xD;
  Indirect calorimetry measurements to assess metabolic needs and body impedance analysis to assess body composition on regular time points&#xD;
  Dedicated and specialized dietician and nurse involvement&#xD;
  Adaptive communication policy (translating to native language) and culturally appropriate food regimens and artificial nutrition.</description>
      <arm_group_label>Cohort</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult ≥ 18 years&#xD;
  &#xD;
            -  ICU stay ≥ 7 days&#xD;
  &#xD;
            -  Ward stay ≥ 3 days&#xD;
  &#xD;
            -  Nutritional therapy not restricted&#xD;
  &#xD;
            -  Heterogeneous diseases&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients &lt; 18 years&#xD;
  &#xD;
            -  ICU &lt; 7 days&#xD;
  &#xD;
            -  Ward stay &lt; 3 days&#xD;
  &#xD;
            -  Advanced Care Planning with impact on nutritional therapy&#xD;
  &#xD;
            -  Patients with palliative care&#xD;
  &#xD;
            -  Metabolic derangements such as metabolic diseases&#xD;
  &#xD;
            -  Pregnancy&#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>Elisabeth De Waele, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universitair Ziekenhuis Brussel, Vrije universiteit Brussel</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zenzi Rosseel, PharmD</last_name>
      <phone>003224763344</phone>
      <email>zenzi.rosseel@uzbrussel.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lotte Buyle, RD</last_name>
      <phone>003224763344</phone>
      <email>lotte.buyle@uzbrussel.be</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
      <investigator_full_name>Elisabeth De Waele</investigator_full_name>
      <investigator_title>Head of Department</investigator_title>
    </responsible_party>
    <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>
  
  
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/NCT06023251
  org study id: EC-2023-236
  nct id: NCT06023251
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective is to increase caloric adequacy in patients who survived critical illness and
        are admitted to the ward by the use of a pro-active inclusive nutritional strategy including
        supplemental parenteral and/or enteral nutrition and/or oral nutritional supplements guided
        by indirect calorimetry.
  
        This enables the investigators to address, within a clinical/scientific context, a recently
        demonstrated but until now relatively neglected 'dark side' of patient care at UZ Brussel,
        comparable to limited global evidence : iatrogenic malnutrition of ICU survivors. The use of
        a newly developed clinical pathway and nutrition strategy (oral, enteral and parenteral) led
        by a single SPoC (Single Point of Contact) for patients surviving intensive care will have a
        clear objective: to address the nutritional deficit in all patients.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Nutrition Adequacy
  time frame: The adequacy will be calculated over the entire ward stay: from date of inclusion till 28 days later or death from any cause, whichever came first.
  description: Increase of caloric adequacy (from 58 to 80%) and protein adequacy (from 52 to 80%) in ICU survivors
  arm group label: Cohort
  arm group type: Other
  description: oral food, enteral nutrition, parenteral nutrition
  intervention type: Other
  intervention name: Clinical Nutrition
  description: Nutritional care plan implementation, including
  A step-up and step-down nutritional protocol guided by caloric and protein ratio
  Monitoring plan including daily nutritional intake assessment by a dietician and (para)medical supervision by a nutrition support pharmacist and nurse concerning dysphagia, refeeding syndrome, electrolytes abnormalities and access issues
  Indirect calorimetry measurements to assess metabolic needs and body impedance analysis to assess body composition on regular time points
  Dedicated and specialized dietician and nurse involvement
  Adaptive communication policy (translating to native language) and culturally appropriate food regimens and artificial nutrition.
  arm group label: Cohort
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Elisabeth De Waele, MD PhD
  role: Principal Investigator
  affiliation: Universitair Ziekenhuis Brussel, Vrije universiteit Brussel
  last name: Zenzi Rosseel, PharmD
  phone: 003224763344
  email: zenzi.rosseel@uzbrussel.be
  last name: Lotte Buyle, RD
  phone: 003224763344
  email: lotte.buyle@uzbrussel.be
  responsible party type: Principal Investigator
  investigator affiliation: Universitair Ziekenhuis Brussel
  investigator full name: Elisabeth De Waele
  investigator title: Head of Department
  mesh term: Malnutrition