<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/NCT02990065</url>
  </required_header>
  <id_info>
    <org_study_id>OPINiB 2016</org_study_id>
    <nct_id>NCT02990065</nct_id>
  </id_info>
  <brief_title>Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients</brief_title>
  <acronym>OPINiB</acronym>
  <official_title>Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients: a Randomized Controlled Trial (OPINiB STUDY)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Padova</source>
  <brief_summary>
    <textblock>
      The purposes of the study are:&#xD;
&#xD;
        -  To strictly ensure the appropriate level of protein and caloric provision in critical&#xD;
           illness, according to the latest literature recommendation;&#xD;
&#xD;
        -  To determine if an association exists between protein intake and nitrogen balance in the&#xD;
           context of a nutrition with appropriate protein provision based on the latest literature&#xD;
           recommendations, rather than in a standard diet with a caloric target weight-based.&#xD;
           Creatinine clearance will also be evaluated to determine if there is any harmful effect&#xD;
           to the kidney secondary to an elevated BUN.&#xD;
&#xD;
        -  To determine if there is a difference in ICU mortality rate between the current&#xD;
           nutrition standard and a hyperproteic nutrition protocol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>nitrogen balance (gr)</measure>
    <time_frame>change from baseline through study completion, an average of 15 days</time_frame>
    <description>(gr)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Protein Deficiency</condition>
  <arm_group>
    <arm_group_label>PROTEIN-FORTIFIED DIET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The protein-fortified diet consists on an energy goal based on REE measurement and a protein target based on the most recent literature recommendations (1.2-2 g/kg/die) (2). Daily caloric requirement, and subsequent protein content, of patients enrolled in the intervention group will be calculated using formulas in Table 1 (10, 12, 13). For each patient will be calculated the Resting Energy Expenditure (REE) and daily protein requirement (1.2-2g/kg/die of body weight registered at the admission) and the corresponding caloric intake (1g = 4 kcal). Finally, total daily caloric intake will be calculated by adding kcal from protein (1g = 4kcal) on kcal from non-protein (50% of REE).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>STANDARD DIET</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The standard diet consists on an energy goal based on weight formula (20-25 kcal/kg/die). According to the ICU nutritional protocol, EN is started at an initial rate of 10ml/h, and increased by 20ml/h every 12 hours in the absence of significant gastric residuals (&lt;250ml), with the aim of reaching the energy goal within 72 hours from admission. The EN formulae used are standard (1-1,5 kcal/ml, 40g/l protein). If enteral nutrition is not tolerated or is not indicated, supplemental PN is used to make up the energy shortfall. The PN formula used is standard (1000 kcal/l, 37 g/l protein).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>PROTEIN SUPPLEMENTATION</intervention_name>
    <arm_group_label>PROTEIN-FORTIFIED DIET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Receiving PN and/or EN nutrition&#xD;
&#xD;
          -  Indwelling urinary catheter&#xD;
&#xD;
          -  Mechanically ventilated patients&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Chronic renal or hepatic failure&#xD;
&#xD;
          -  Current or history (past 6 months) of GI bleeding&#xD;
&#xD;
          -  BMI &gt;30 kg/m2 o &lt;18 kg/m2&#xD;
&#xD;
          -  Terminally ill patients&#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>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Padova</investigator_affiliation>
    <investigator_full_name>Dario Gregori</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>PROTEIN SUPPLEMENTATION</keyword>
  <keyword>NUTRITIONAL STATUS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Protein Deficiency</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/NCT02990065
org study id: OPINiB 2016
nct id: NCT02990065
lead sponsor: 
The purposes of the study are:

        -  To strictly ensure the appropriate level of protein and caloric provision in critical
           illness, according to the latest literature recommendation;

        -  To determine if an association exists between protein intake and nitrogen balance in the
           context of a nutrition with appropriate protein provision based on the latest literature
           recommendations, rather than in a standard diet with a caloric target weight-based.
           Creatinine clearance will also be evaluated to determine if there is any harmful effect
           to the kidney secondary to an elevated BUN.

        -  To determine if there is a difference in ICU mortality rate between the current
           nutrition standard and a hyperproteic nutrition protocol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: nitrogen balance (gr)
time frame: change from baseline through study completion, an average of 15 days
description: (gr)
arm group label: PROTEIN-FORTIFIED DIET
arm group type: Experimental
description: The protein-fortified diet consists on an energy goal based on REE measurement and a protein target based on the most recent literature recommendations (1.2-2 g/kg/die) (2). Daily caloric requirement, and subsequent protein content, of patients enrolled in the intervention group will be calculated using formulas in Table 1 (10, 12, 13). For each patient will be calculated the Resting Energy Expenditure (REE) and daily protein requirement (1.2-2g/kg/die of body weight registered at the admission) and the corresponding caloric intake (1g = 4 kcal). Finally, total daily caloric intake will be calculated by adding kcal from protein (1g = 4kcal) on kcal from non-protein (50% of REE).
arm group label: STANDARD DIET
arm group type: No Intervention
description: The standard diet consists on an energy goal based on weight formula (20-25 kcal/kg/die). According to the ICU nutritional protocol, EN is started at an initial rate of 10ml/h, and increased by 20ml/h every 12 hours in the absence of significant gastric residuals (<250ml), with the aim of reaching the energy goal within 72 hours from admission. The EN formulae used are standard (1-1,5 kcal/ml, 40g/l protein). If enteral nutrition is not tolerated or is not indicated, supplemental PN is used to make up the energy shortfall. The PN formula used is standard (1000 kcal/l, 37 g/l protein).
intervention type: Dietary Supplement
intervention name: PROTEIN SUPPLEMENTATION
arm group label: PROTEIN-FORTIFIED DIET
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Padova
investigator full name: Dario Gregori
investigator title: Associate Professor
mesh term: Protein Deficiency