<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/NCT03277300</url>
  </required_header>
  <id_info>
    <org_study_id>EN&amp;PN</org_study_id>
    <nct_id>NCT03277300</nct_id>
  </id_info>
  <brief_title>Enteral and Parenteral Feeding in Critically Ill Patients</brief_title>
  <official_title>Enteral and Parenteral Feeding in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Supplementation of insufficient enteral nutrition with parenteral nutrition may optimize&#xD;
      nutritional support and avert negative energy balance in critically ill patients, thereby&#xD;
      improving outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malnutrition is a common and serious problem in intensive care units. Negative energy balance&#xD;
      has been associated with increased morbidity and mortality in critically ill patients. The&#xD;
      increased incidence of complications related to malnutrition correlates with increased length&#xD;
      of hospital stay and overall health care costs. Although early enteral nutrition is the&#xD;
      preferred method of feeding critically ill patients, enteral nutrition alone often fails to&#xD;
      supply adequate calories and nutrients to critically ill patients, who are frequently&#xD;
      hypermetabolic.&#xD;
&#xD;
      Artificial nutrition support has evolved into a primary therapeutic intervention to prevent&#xD;
      metabolic deterioration and loss of lean body mass with the aim to improve the outcome of&#xD;
      critically ill patients. Apart from the timing of initiation and the targeted amount of&#xD;
      macronutrients, the route of delivery is viewed as an important determinant of the effect of&#xD;
      the nutritional intervention.&#xD;
&#xD;
      Using the enteral route is considered to be more physiologic, providing nutritional and&#xD;
      various non-nutritional benefits including maintenance of structural and functional gut&#xD;
      integrity as well as preserving intestinal microbial diversity.&#xD;
&#xD;
      The disadvantage of enteral nutrition is related to a potential lower nutritional adequacy&#xD;
      particularly in the acute disease phase and in the presence of gastrointestinal dysfunction.&#xD;
&#xD;
      In contrast, parenteral nutrition may better secure the intended nutritional intake but is&#xD;
      associated with more infectious complications, most likely due to hyperalimentation and&#xD;
      hyperglycemia.&#xD;
&#xD;
      Supplementation of insufficient enteral nutrition with parenteral nutrition may optimize&#xD;
      nutritional support and avert negative energy balance in critically ill patients, thereby&#xD;
      improving outcome.&#xD;
&#xD;
      Combining parenteral nutrition with enteral nutrition constitutes a strategy to prevent&#xD;
      nutritional deficit but may increase risk of overfeeding, which has been associated with&#xD;
      liver dysfunction, infection, and prolonged ventilatory support.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2018</start_date>
  <completion_date type="Anticipated">January 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2019</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>ts Overall mortality</measure>
    <time_frame>one year</time_frame>
    <description>Determined by hospital records.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Critical Illness</condition>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>dietary supplement</intervention_name>
    <description>good dietary supplement for critically ill patients</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Data will be collected and analyzed using SPSS version 20. Normally distributed data will&#xD;
        be expressed in form of mean and SD while not normally distributed data will be expressed&#xD;
        in form of median and range. Nominal data will be expressed in form of frequency&#xD;
        (percentage). P value will be significant if &lt; 0.05.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted to CCU (critical care unit)who are in need for either enteral or&#xD;
             parenteral during duration of the study will be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>NoorEldeen AbdElazeem, professor</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Mohamed</last_name>
    <phone>+2001140148703</phone>
    <email>ahmedeltemway1989@outlook.com</email>
  </overall_contact>
  <reference>
    <citation>DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986 Sep;7(3):177-88. doi: 10.1016/0197-2456(86)90046-2.</citation>
    <PMID>3802833</PMID>
  </reference>
  <reference>
    <citation>Cahill NE, Dhaliwal R, Day AG, Jiang X, Heyland DK. Nutrition therapy in the critical care setting: what is &quot;best achievable&quot; practice? An international multicenter observational study. Crit Care Med. 2010 Feb;38(2):395-401. doi: 10.1097/CCM.0b013e3181c0263d.</citation>
    <PMID>19851094</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed Abdelhamid</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT03277300
org study id: EN&PN
nct id: NCT03277300
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Supplementation of insufficient enteral nutrition with parenteral nutrition may optimize
      nutritional support and avert negative energy balance in critically ill patients, thereby
      improving outcome.
Malnutrition is a common and serious problem in intensive care units. Negative energy balance
      has been associated with increased morbidity and mortality in critically ill patients. The
      increased incidence of complications related to malnutrition correlates with increased length
      of hospital stay and overall health care costs. Although early enteral nutrition is the
      preferred method of feeding critically ill patients, enteral nutrition alone often fails to
      supply adequate calories and nutrients to critically ill patients, who are frequently
      hypermetabolic.

      Artificial nutrition support has evolved into a primary therapeutic intervention to prevent
      metabolic deterioration and loss of lean body mass with the aim to improve the outcome of
      critically ill patients. Apart from the timing of initiation and the targeted amount of
      macronutrients, the route of delivery is viewed as an important determinant of the effect of
      the nutritional intervention.

      Using the enteral route is considered to be more physiologic, providing nutritional and
      various non-nutritional benefits including maintenance of structural and functional gut
      integrity as well as preserving intestinal microbial diversity.

      The disadvantage of enteral nutrition is related to a potential lower nutritional adequacy
      particularly in the acute disease phase and in the presence of gastrointestinal dysfunction.

      In contrast, parenteral nutrition may better secure the intended nutritional intake but is
      associated with more infectious complications, most likely due to hyperalimentation and
      hyperglycemia.

      Supplementation of insufficient enteral nutrition with parenteral nutrition may optimize
      nutritional support and avert negative energy balance in critically ill patients, thereby
      improving outcome.

      Combining parenteral nutrition with enteral nutrition constitutes a strategy to prevent
      nutritional deficit but may increase risk of overfeeding, which has been associated with
      liver dysfunction, infection, and prolonged ventilatory support.
observational model: Cohort
time perspective: Prospective
measure: ts Overall mortality
time frame: one year
description: Determined by hospital records.
intervention type: Dietary Supplement
intervention name: dietary supplement
description: good dietary supplement for critically ill patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
last name: NoorEldeen AbdElazeem, professor
role: Study Chair
affiliation: Assiut University
last name: Ahmed Mohamed
phone: +2001140148703
email: ahmedeltemway1989@outlook.com
citation: DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986 Sep;7(3):177-88. doi: 10.1016/0197-2456(86)90046-2.
PMID: 3802833
citation: Cahill NE, Dhaliwal R, Day AG, Jiang X, Heyland DK. Nutrition therapy in the critical care setting: what is "best achievable" practice? An international multicenter observational study. Crit Care Med. 2010 Feb;38(2):395-401. doi: 10.1097/CCM.0b013e3181c0263d.
PMID: 19851094
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohamed Abdelhamid
investigator title: doctor
mesh term: Critical Illness