<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/NCT02976155</url>
  </required_header>
  <id_info>
    <org_study_id>87783921</org_study_id>
    <nct_id>NCT02976155</nct_id>
  </id_info>
  <brief_title>The Effect of Standardized Enteral Nutrition on Critically Ill Patients</brief_title>
  <official_title>The Effect of a Standard Enteral Nutrition Protocol on Critically Ill Patients: a Multiple-center, Prospective, Before-after Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Emergency Medicine, People's Hospital of Shaoxing, Shaoxing, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Emergency Medicine, Wenzhou Central Hospital, Wenzhou, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Emergency Medicine, The First People's Hospital of Hangzhou, Hangzhou, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Emergency Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Emergency Medicine, Sir Run-Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emergency Department, The First People's Hospital of Huzhou, Huzhou, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Critical Care Medicine, The First People's Hospital of Xiaoshan District, Hangzhou, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emergency Department, Jinhua Hospital of Zhejiang University, Jinhua, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Critical Care Medicine, The First People's Hospital of Fuyang district, Hangzhou, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Critical Care Medicine, Beilun District People's Hospital, Ningbo, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emergency Department, The Affiliated Hospital of Hangzhou Normal University, Hangzhou, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Emergency Intensive Care Unit, Ruian people's Hospital, Ruian, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Emergency Medicine, Yuyao People's Hospital, Medical School of Ningbo University, Ningbo, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Emergency Intensive Care Unit, The Second Hospital of Jiaxing, No 1518, Huanchengbei Rd, Jiaxing, China.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate whether a standard enteral nutrition protocol can&#xD;
      improve the efficiency in achieving nutritional goals and improve prognosis in critically ill&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As investigators all know, the nutrition status in critically ill patients is associated with&#xD;
      the prognosis of these patients. And it has been confirmed that early enteral nutrition&#xD;
      results in better outcome. However,some epidemiological investigation reported that in most&#xD;
      intensive care unit, the phenomenon of delayed feeding or under feeding are not uncommon. In&#xD;
      2007, a study reported that the percentage of early enteral nutrition within 48h is 64%,&#xD;
      based on mechanical ventilated patients in 208 intensive care unit nationally. Other study&#xD;
      indicated that the calorie supported by the enteral nutrition only constitute 50% of the&#xD;
      target calorie. Several studies have showed that the application of a standard enteral&#xD;
      nutrition protocol could result in an improvement in the delivery of enteral feedings to&#xD;
      patients. However, there is no such study in China.The goal of this study is to evaluate&#xD;
      whether a standard enteral nutrition protocol can improve the efficiency in achieving&#xD;
      nutritional goals and improve prognosis in critically ill patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Before-after study model</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition</measure>
    <time_frame>7 days after ICU admission</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The time from hospital admission to the begain Enteral nutrition.</measure>
    <time_frame>7 days after ICU admission</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The time from hospital admission to achieve the target calorie.</measure>
    <time_frame>7 days after ICU admission</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of patients receiving parenteral nutrition in patients receiving any type of nutrition</measure>
    <time_frame>7 days after ICU admission</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of patients receiving Enteral plus supplement parenteral in patients receiving any type of nutrition</measure>
    <time_frame>7 days after ICU admission</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU mortality.</measure>
    <time_frame>From date of the ICU admission until discharge form ICU,assessed up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality.</measure>
    <time_frame>From date of the ICU admission until discharge form hospital,assessed up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>From date of the ICU admission until discharge form ICU,assessed up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation.</measure>
    <time_frame>From date of the initiation of mechanical ventilation until weaning,assessed up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU fee.</measure>
    <time_frame>From date of the ICU admission until discharge form ICU,assessed up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of complications(Diarrhea , abdominal distension, nausea and vomiting.)</measure>
    <time_frame>From date of the ICU admission until discharge form ICU,assessed up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">439</enrollment>
  <condition>Critically Ill</condition>
  <arm_group>
    <arm_group_label>Pre-intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>enteral nutrition according routine practice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention in this arm is the application of a standard enteral nutrition protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A standard enteral nutrition protocol</intervention_name>
    <description>Patients in the experimental arm, the practice of enteral nutrition will based on a standard protocol. The core content of this protocol includes five step：1. Whether the participants need nutrition therapy? 2. The choice of nutrition way? 3. Nasogastric tube or nasointestinal tube? 4. The choice of enteral nutrition type? 5. The target calorie and protein of the participants? And how to achieve these target？(In this study, the practice of the above protocol is the only intervention).</description>
    <arm_group_label>Post-intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Critically ill patients who is expected the length of ICU stay for more than 3 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who can obtain enough calorie through independent oral feeding. Patients aged&#xD;
             less than 18 years. Patients who are pregnant or breastfeeding. Patients who are&#xD;
             burned. Patients with malignant tumor terminal stages of diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The second affiliated hospital of Zhejiang university, school of medicine.</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>July 14, 2021</last_update_submitted>
  <last_update_submitted_qc>July 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>critically ill, intensive care, enteral nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02976155
org study id: 87783921
nct id: NCT02976155
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The goal of this study is to evaluate whether a standard enteral nutrition protocol can
      improve the efficiency in achieving nutritional goals and improve prognosis in critically ill
      patients.
As investigators all know, the nutrition status in critically ill patients is associated with
      the prognosis of these patients. And it has been confirmed that early enteral nutrition
      results in better outcome. However,some epidemiological investigation reported that in most
      intensive care unit, the phenomenon of delayed feeding or under feeding are not uncommon. In
      2007, a study reported that the percentage of early enteral nutrition within 48h is 64%,
      based on mechanical ventilated patients in 208 intensive care unit nationally. Other study
      indicated that the calorie supported by the enteral nutrition only constitute 50% of the
      target calorie. Several studies have showed that the application of a standard enteral
      nutrition protocol could result in an improvement in the delivery of enteral feedings to
      patients. However, there is no such study in China.The goal of this study is to evaluate
      whether a standard enteral nutrition protocol can improve the efficiency in achieving
      nutritional goals and improve prognosis in critically ill patients.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Before-after study model
primary purpose: Treatment
masking: None (Open Label)
measure: The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition
time frame: 7 days after ICU admission
measure: The time from hospital admission to the begain Enteral nutrition.
time frame: 7 days after ICU admission
measure: The time from hospital admission to achieve the target calorie.
time frame: 7 days after ICU admission
measure: The proportion of patients receiving parenteral nutrition in patients receiving any type of nutrition
time frame: 7 days after ICU admission
measure: The proportion of patients receiving Enteral plus supplement parenteral in patients receiving any type of nutrition
time frame: 7 days after ICU admission
measure: ICU mortality.
time frame: From date of the ICU admission until discharge form ICU,assessed up to 12 months
measure: Hospital mortality.
time frame: From date of the ICU admission until discharge form hospital,assessed up to 12 months
measure: ICU length of stay
time frame: From date of the ICU admission until discharge form ICU,assessed up to 12 months
measure: Duration of mechanical ventilation.
time frame: From date of the initiation of mechanical ventilation until weaning,assessed up to 12 months
measure: ICU fee.
time frame: From date of the ICU admission until discharge form ICU,assessed up to 12 months
measure: The incidence of complications(Diarrhea , abdominal distension, nausea and vomiting.)
time frame: From date of the ICU admission until discharge form ICU,assessed up to 12 months
arm group label: Pre-intervention
arm group type: No Intervention
description: enteral nutrition according routine practice
arm group label: Post-intervention
arm group type: Experimental
description: The intervention in this arm is the application of a standard enteral nutrition protocol
intervention type: Other
intervention name: A standard enteral nutrition protocol
description: Patients in the experimental arm, the practice of enteral nutrition will based on a standard protocol. The core content of this protocol includes five step：1. Whether the participants need nutrition therapy? 2. The choice of nutrition way? 3. Nasogastric tube or nasointestinal tube? 4. The choice of enteral nutrition type? 5. The target calorie and protein of the participants? And how to achieve these target？(In this study, the practice of the above protocol is the only intervention).
arm group label: Post-intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: Undecided