<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/NCT03017079</url>
  </required_header>
  <id_info>
    <org_study_id>lukongmiao123</org_study_id>
    <nct_id>NCT03017079</nct_id>
  </id_info>
  <brief_title>A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients</brief_title>
  <official_title>A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Malnutrition and underfeeding are major challenges in caring for critically ill patients.&#xD;
      Continuous feeding were thought to be better tolerated by patients with the limited&#xD;
      absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube&#xD;
      clogging and required the patient to be attached to an infusion pump for significant periods&#xD;
      of time. Intermittent infusion resembled more physiological feeding process, which allowed&#xD;
      greater patient mobility and might reach goal enteral calories earlier, and the latter were&#xD;
      considered to effectively decrease the length of stay (LOS)-in-hospital and mortality.&#xD;
      However, it also had some previous study found that intermittent infusion had more&#xD;
      complications, such as diarrhea, regurgitation than continuous. Some study found that it was&#xD;
      an efficient way to prevent aspiration and reflux by increasing the enteral nutrient solution&#xD;
      viscosity and improve bolus intermittent feeding intolerance. The primary goal of this was to&#xD;
      study whether receiving semi-solidification of nutrients could increase the percent&#xD;
      prescribed calories received by improving the feeding intolerance, and secondary goal was to&#xD;
      observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital, lung&#xD;
      infection, 30-days mortality and the glycemic variability (GV).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enteral nutrition (EN) therapy is an essential part in critically ill patients，and can be&#xD;
      administered on a continuous or intermittent, but there were no consensus on which should be&#xD;
      adopted. Continuous feeding were thought to be better tolerated by patients with the limited&#xD;
      absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube&#xD;
      clogging and required the patient to be attached to an infusion pump for significant periods&#xD;
      of time. Intermittent infusion resembled more physiological feeding process, which allowed&#xD;
      greater patient mobility and might reach goal enteral calories earlier, and the latter were&#xD;
      considered to effectively decrease the LOS-in-hospital and mortality. However, it also had&#xD;
      some previous study found that intermittent infusion had more complications, such as&#xD;
      diarrhea, regurgitation than continuous.&#xD;
&#xD;
      Recently, some study found that it was an efficient way to prevent aspiration and reflux by&#xD;
      increasing the enteral nutrient solution viscosity and improve bolus intermittent feeding&#xD;
      intolerance. In dementia or Parkinson's patients, one study showed that high-viscosity liquid&#xD;
      meal could decrease the incidence of aspiration, compared with the thin liquid, but the study&#xD;
      about the viscosity of nutrition was little and the sample size was small.&#xD;
&#xD;
      In this study, the primary goal of this was to study whether receiving semi-solidification of&#xD;
      nutrients could increase the percent prescribed calories received by improving the feeding&#xD;
      intolerance, and secondary goal was to observing the effect of semi-solid nutrient to the LOS&#xD;
      of ICU and in-hospital, lung infection, 30-days mortality and the glycemic variability (GV).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">March 1, 2017</completion_date>
  <primary_completion_date type="Actual">March 1, 2017</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>the Ratio of the Enteral Nutrition</measure>
    <time_frame>3 days after receiving enteral nutrition</time_frame>
    <description>the ratio of the enteral nutrition=administered volume of enteral nutrition / prescribed volume of nutrition X 100%; This ratio fluctuates between 0 and 100%, and the higher the ratio, the higher the execution rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the Patient of Feeding Intolerance（FI）</measure>
    <time_frame>3 days</time_frame>
    <description>the definition of FI was included one of the conditions:diarrhea, vomiting, regurgitation, obvious bowel distension and GRV&gt;200mL.&#xD;
Due to the small sample size, only the number of patients who occurred was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Patients With Lung Infection</measure>
    <time_frame>7 days</time_frame>
    <description>patient contain the following three conditions:&#xD;
1.Sputum volume increased or Sputum properties change;2.CT Scan-Chest suggest that there was lung infection; 3.CRP and / or PCT increased</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-days Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>dead within 30 days in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Glycemic Variability(GV)</measure>
    <time_frame>3 days</time_frame>
    <description>Divided into three grades:I:GV less than 4mmol/24h; II 4-6mmol/24h;III more than 6mmol/24h</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay (LOS)</measure>
    <time_frame>30 days</time_frame>
    <description>every participators stayed in hospital</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Nutrition, Enteral</condition>
  <arm_group>
    <arm_group_label>semi-solidification with nutrient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.&#xD;
Intervention: Other: bolus Intermittent enteral feeding</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard enteral nutrition</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.&#xD;
Intervention: Other: Standard enteral feeding</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>semi-solid agent with standard enteral feeding</intervention_name>
    <description>after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 minutes</description>
    <arm_group_label>semi-solidification with nutrient</arm_group_label>
    <other_name>semi-solidification of nutrient</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard enteral feeding</intervention_name>
    <description>Intermittent enteral feeding is applied less than 60 minutes</description>
    <arm_group_label>Standard enteral nutrition</arm_group_label>
    <other_name>standard enteral nutrition</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1)14 years and older, who received EN for more than 72 hours, were eligible for inclusion&#xD;
        (2) all patients started on EN by nasogastric tube&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. received EN &lt;72 hours&#xD;
&#xD;
          2. received EN prior to ICU admission&#xD;
&#xD;
          3. had acute pulmonary infection&#xD;
&#xD;
          4. had history of Gastrointestinal surgery&#xD;
&#xD;
          5. had contraindications of EN, such as intestinal obstruction (mechanical or paralytic&#xD;
             ileus).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>man huang, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second affiliated hospital, Zhejiang university school of medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Second affiliated hospital, Zhejiang university school of medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Peev MP, Yeh DD, Quraishi SA, Osler P, Chang Y, Gillis E, Albano CE, Darak S, Velmahos GC. Causes and consequences of interrupted enteral nutrition: a prospective observational study in critically ill surgical patients. JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):21-7. doi: 10.1177/0148607114526887. Epub 2014 Apr 7.</citation>
    <PMID>24714361</PMID>
  </reference>
  <results_reference>
    <citation>Evans DC, Forbes R, Jones C, Cotterman R, Njoku C, Thongrong C, Tulman D, Bergese SD, Thomas S, Papadimos TJ, Stawicki SP. Continuous versus bolus tube feeds: Does the modality affect glycemic variability, tube feeding volume, caloric intake, or insulin utilization? Int J Crit Illn Inj Sci. 2016 Jan-Mar;6(1):9-15. doi: 10.4103/2229-5151.177357.</citation>
    <PMID>27051616</PMID>
  </results_reference>
  <results_reference>
    <citation>MacLeod JB, Lefton J, Houghton D, Roland C, Doherty J, Cohn SM, Barquist ES. Prospective randomized control trial of intermittent versus continuous gastric feeds for critically ill trauma patients. J Trauma. 2007 Jul;63(1):57-61. doi: 10.1097/01.ta.0000249294.58703.11.</citation>
    <PMID>17622869</PMID>
  </results_reference>
  <results_reference>
    <citation>Taylor BE, McClave SA, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society of Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Crit Care Med. 2016 Feb;44(2):390-438. doi: 10.1097/CCM.0000000000001525. No abstract available.</citation>
    <PMID>26771786</PMID>
  </results_reference>
  <results_reference>
    <citation>Logemann JA, Gensler G, Robbins J, Lindblad AS, Brandt D, Hind JA, Kosek S, Dikeman K, Kazandjian M, Gramigna GD, Lundy D, McGarvey-Toler S, Miller Gardner PJ. A randomized study of three interventions for aspiration of thin liquids in patients with dementia or Parkinson's disease. J Speech Lang Hear Res. 2008 Feb;51(1):173-83. doi: 10.1044/1092-4388(2008/013).</citation>
    <PMID>18230864</PMID>
  </results_reference>
  <results_reference>
    <citation>Bardhan KD, Strugala V, Dettmar PW. Reflux revisited: advancing the role of pepsin. Int J Otolaryngol. 2012;2012:646901. doi: 10.1155/2012/646901. Epub 2011 Nov 10.</citation>
    <PMID>22242022</PMID>
  </results_reference>
  <results_reference>
    <citation>Hayat JO, Gabieta-Somnez S, Yazaki E, Kang JY, Woodcock A, Dettmar P, Mabary J, Knowles CH, Sifrim D. Pepsin in saliva for the diagnosis of gastro-oesophageal reflux disease. Gut. 2015 Mar;64(3):373-80. doi: 10.1136/gutjnl-2014-307049. Epub 2014 May 7.</citation>
    <PMID>24812000</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <results_first_submitted>September 11, 2018</results_first_submitted>
  <results_first_submitted_qc>October 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 2, 2021</results_first_posted>
  <last_update_submitted>October 3, 2021</last_update_submitted>
  <last_update_submitted_qc>October 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_affiliation>
    <investigator_full_name>Man Huang, Ph.D</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Semi-solidification</keyword>
  <keyword>caloric debt</keyword>
  <keyword>enteral nutrition</keyword>
  <keyword>critical illness</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 24, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03017079/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 24, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03017079/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 24, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03017079/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Semi-solidification With Nutrient</title>
          <description>semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.&#xD;
Intervention: Other: bolus Intermittent enteral feeding&#xD;
semi-solid agent: after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins</description>
        </group>
        <group group_id="P2">
          <title>Standard Enteral Nutrition</title>
          <description>After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.&#xD;
Intervention: Other: Standard enteral feeding&#xD;
standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Semi-solidification With Nutrient</title>
          <description>semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.&#xD;
Intervention: Other: bolus Intermittent enteral feeding&#xD;
semi-solid agent: after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins</description>
        </group>
        <group group_id="B2">
          <title>Standard Enteral Nutrition</title>
          <description>After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.&#xD;
Intervention: Other: Standard enteral feeding&#xD;
standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.93" spread="20.96"/>
                    <measurement group_id="B2" value="52.14" spread="13.77"/>
                    <measurement group_id="B3" value="53.54" spread="17.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NRS 2002</title>
          <description>NRS 2002 range from 0 to 7,and The higher the score, the higher the nutritional risk</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.14" spread="0.77"/>
                    <measurement group_id="B2" value="2.86" spread="0.95"/>
                    <measurement group_id="B3" value="3" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>the Ratio of the Enteral Nutrition</title>
        <description>the ratio of the enteral nutrition=administered volume of enteral nutrition / prescribed volume of nutrition X 100%; This ratio fluctuates between 0 and 100%, and the higher the ratio, the higher the execution rate</description>
        <time_frame>3 days after receiving enteral nutrition</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Feeding With Semi-solid Nutrients</title>
            <description>semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.</description>
          </group>
          <group group_id="O2">
            <title>Standard Enteral Feeding</title>
            <description>After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.&#xD;
Intervention: Other: Standard enteral feeding&#xD;
standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins</description>
          </group>
        </group_list>
        <measure>
          <title>the Ratio of the Enteral Nutrition</title>
          <description>the ratio of the enteral nutrition=administered volume of enteral nutrition / prescribed volume of nutrition X 100%; This ratio fluctuates between 0 and 100%, and the higher the ratio, the higher the execution rate</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="0.067"/>
                    <measurement group_id="O2" value="0.73" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Patient of Feeding Intolerance（FI）</title>
        <description>the definition of FI was included one of the conditions:diarrhea, vomiting, regurgitation, obvious bowel distension and GRV&gt;200mL.&#xD;
Due to the small sample size, only the number of patients who occurred was recorded.</description>
        <time_frame>3 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Feeding</title>
            <description>After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.&#xD;
Intervention: Other: Standard enteral feeding&#xD;
standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins</description>
          </group>
          <group group_id="O2">
            <title>Intermittent Feeding With Semi-solid Nutrients</title>
            <description>semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.&#xD;
Intervention: Other: bolus Intermittent enteral feeding&#xD;
semi-solid agent: after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins</description>
          </group>
        </group_list>
        <measure>
          <title>the Patient of Feeding Intolerance（FI）</title>
          <description>the definition of FI was included one of the conditions:diarrhea, vomiting, regurgitation, obvious bowel distension and GRV&gt;200mL.&#xD;
Due to the small sample size, only the number of patients who occurred was recorded.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>P=.046</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>a:0.05;β：0.01 P=.046</non_inferiority_desc>
            <p_value>0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Patients With Lung Infection</title>
        <description>patient contain the following three conditions:&#xD;
1.Sputum volume increased or Sputum properties change;2.CT Scan-Chest suggest that there was lung infection; 3.CRP and / or PCT increased</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Feeding</title>
            <description>After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.&#xD;
Intervention: Other: Standard enteral feeding&#xD;
standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins</description>
          </group>
          <group group_id="O2">
            <title>Intermittent Feeding With Semi-solid Nutrients</title>
            <description>semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.&#xD;
Intervention: Other: bolus Intermittent enteral feeding&#xD;
semi-solid agent: after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins</description>
          </group>
        </group_list>
        <measure>
          <title>the Patients With Lung Infection</title>
          <description>patient contain the following three conditions:&#xD;
1.Sputum volume increased or Sputum properties change;2.CT Scan-Chest suggest that there was lung infection; 3.CRP and / or PCT increased</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>a 0.05</non_inferiority_desc>
            <p_value>0.05</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.05</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>30-days Mortality</title>
        <description>dead within 30 days in ICU</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Feeding With Semi-solid Nutrients</title>
            <description>semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.</description>
          </group>
          <group group_id="O2">
            <title>Intermittent Feeding</title>
            <description>After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.</description>
          </group>
        </group_list>
        <measure>
          <title>30-days Mortality</title>
          <description>dead within 30 days in ICU</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>The number of deaths within 30 days after ICU</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The number of live after 30 days in ICU</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>Chi-squared, Corrected</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Glycemic Variability(GV)</title>
        <description>Divided into three grades:I:GV less than 4mmol/24h; II 4-6mmol/24h;III more than 6mmol/24h</description>
        <time_frame>3 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Feeding With Semi-solid Nutrients</title>
            <description>the initial feeds of 100 to 300mL every 4 to 8 hours and the semi-solid agent feeded before the EN application within 1 hour, which is low methoxy pectin gel and water-soluble dietary fiber form apple and citrus peel by binding to calcium ions in EN to increase the viscosity, but do not change any chemical properties of EN. This was repeated twice and, if tolerated, they were advanced by 100 to 300mL every 1 to 2 days to the volume goal.</description>
          </group>
          <group group_id="O2">
            <title>Intermittent Feeding</title>
            <description>The intermittent protocol involved initial feeds of 100 to 300mL every 4 to 8hours. This was repeated twice and, if tolerated, they were advanced by 100 to 300mL every 1 to 2 days to the volume goal. Each intermittent feeding was delivered via an enteral feeding pump during a 30- to 60-minute period of time.</description>
          </group>
        </group_list>
        <measure>
          <title>the Glycemic Variability(GV)</title>
          <description>Divided into three grades:I:GV less than 4mmol/24h; II 4-6mmol/24h;III more than 6mmol/24h</description>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1d-0h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.514" spread="2.2309"/>
                    <measurement group_id="O2" value="8.457" spread="2.9456"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1d-4h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.336" spread="2.1653"/>
                    <measurement group_id="O2" value="9.700" spread="3.1001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1d-8h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.229" spread="3.2587"/>
                    <measurement group_id="O2" value="9.664" spread="3.1023"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1d-12h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.342857" spread="3.1353357"/>
                    <measurement group_id="O2" value="8.985714" spread="3.2846630"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1d-16h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.635714" spread="2.4069154"/>
                    <measurement group_id="O2" value="8.992857" spread="3.1086639"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1d-20h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.064286" spread="1.9727400"/>
                    <measurement group_id="O2" value="8.721429" spread="2.5137097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2d-0h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.436" spread="2.2016"/>
                    <measurement group_id="O2" value="8.686" spread="2.9493"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2d-4h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.857" spread="2.5687"/>
                    <measurement group_id="O2" value="9.450" spread="3.1889"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2d-8h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.471" spread="3.0698"/>
                    <measurement group_id="O2" value="9.064" spread="2.8527"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2d-12h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.543" spread="3.5213"/>
                    <measurement group_id="O2" value="9.514" spread="3.6367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2d-16h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.343" spread="3.4469"/>
                    <measurement group_id="O2" value="8.821" spread="3.6413"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2d-20h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.807" spread="3.4130"/>
                    <measurement group_id="O2" value="7.807" spread="2.8073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3d-0h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.135714" spread="2.5548166"/>
                    <measurement group_id="O2" value="8.250000" spread="4.3164711"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3d-4h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.579" spread="2.8282"/>
                    <measurement group_id="O2" value="9.486" spread="3.7223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3d-8h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.121" spread="2.8011"/>
                    <measurement group_id="O2" value="8.879" spread="3.0238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3d-12h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.721" spread="2.8072"/>
                    <measurement group_id="O2" value="9.429" spread="3.0648"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3d-16h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.328571" spread="3.2257208"/>
                    <measurement group_id="O2" value="8.935714" spread="2.2210902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3d-20h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.250000" spread="2.3299884"/>
                    <measurement group_id="O2" value="7.957143" spread="2.0129253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay (LOS)</title>
        <description>every participators stayed in hospital</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Feeding With Semi-solid Nutrients</title>
            <description>intermittent feeding with semi-solid nutrients:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.&#xD;
Intervention: Other: bolus Intermittent enteral feeding&#xD;
semi-solid agent: after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins</description>
          </group>
          <group group_id="O2">
            <title>Intermittent Feeding</title>
            <description>After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.&#xD;
Intervention: Other: Standard enteral feeding&#xD;
standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay (LOS)</title>
          <description>every participators stayed in hospital</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.07" spread="25.71"/>
                    <measurement group_id="O2" value="14.36" spread="7.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>According to the rule of a=0.05, P&lt;0.05 means that the hypothesis was true</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>Chi-squared, Corrected</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Total follow-up 1 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Standard Enteral Nutrition</title>
          <description>We only record the daily enteral nutrition prescribed and received as well as the acute complications of enteral nutrition (EN) such as diarrhea, vomiting, regurgitation, bowel distension and lung infection in this study, no other adverse was found</description>
        </group>
        <group group_id="E2">
          <title>Semi-solidification With Nutrient</title>
          <description>We only record the daily enteral nutrition prescribed and received as well as the acute complications of enteral nutrition (EN) such as diarrhea, vomiting, regurgitation, bowel distension and lung infection in this study, no other adverse was found</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr</name_or_title>
      <organization>THE SECOND AFFILIATED HOSPITAL ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE</organization>
      <phone>18817821529</phone>
      <email>hm198699@126.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03017079
org study id: lukongmiao123
nct id: NCT03017079
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Malnutrition and underfeeding are major challenges in caring for critically ill patients.
      Continuous feeding were thought to be better tolerated by patients with the limited
      absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube
      clogging and required the patient to be attached to an infusion pump for significant periods
      of time. Intermittent infusion resembled more physiological feeding process, which allowed
      greater patient mobility and might reach goal enteral calories earlier, and the latter were
      considered to effectively decrease the length of stay (LOS)-in-hospital and mortality.
      However, it also had some previous study found that intermittent infusion had more
      complications, such as diarrhea, regurgitation than continuous. Some study found that it was
      an efficient way to prevent aspiration and reflux by increasing the enteral nutrient solution
      viscosity and improve bolus intermittent feeding intolerance. The primary goal of this was to
      study whether receiving semi-solidification of nutrients could increase the percent
      prescribed calories received by improving the feeding intolerance, and secondary goal was to
      observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital, lung
      infection, 30-days mortality and the glycemic variability (GV).
Enteral nutrition (EN) therapy is an essential part in critically ill patients，and can be
      administered on a continuous or intermittent, but there were no consensus on which should be
      adopted. Continuous feeding were thought to be better tolerated by patients with the limited
      absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube
      clogging and required the patient to be attached to an infusion pump for significant periods
      of time. Intermittent infusion resembled more physiological feeding process, which allowed
      greater patient mobility and might reach goal enteral calories earlier, and the latter were
      considered to effectively decrease the LOS-in-hospital and mortality. However, it also had
      some previous study found that intermittent infusion had more complications, such as
      diarrhea, regurgitation than continuous.

      Recently, some study found that it was an efficient way to prevent aspiration and reflux by
      increasing the enteral nutrient solution viscosity and improve bolus intermittent feeding
      intolerance. In dementia or Parkinson's patients, one study showed that high-viscosity liquid
      meal could decrease the incidence of aspiration, compared with the thin liquid, but the study
      about the viscosity of nutrition was little and the sample size was small.

      In this study, the primary goal of this was to study whether receiving semi-solidification of
      nutrients could increase the percent prescribed calories received by improving the feeding
      intolerance, and secondary goal was to observing the effect of semi-solid nutrient to the LOS
      of ICU and in-hospital, lung infection, 30-days mortality and the glycemic variability (GV).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: the Ratio of the Enteral Nutrition
time frame: 3 days after receiving enteral nutrition
description: the ratio of the enteral nutrition=administered volume of enteral nutrition / prescribed volume of nutrition X 100%; This ratio fluctuates between 0 and 100%, and the higher the ratio, the higher the execution rate
measure: the Patient of Feeding Intolerance（FI）
time frame: 3 days
description: the definition of FI was included one of the conditions:diarrhea, vomiting, regurgitation, obvious bowel distension and GRV>200mL.
Due to the small sample size, only the number of patients who occurred was recorded.
measure: the Patients With Lung Infection
time frame: 7 days
description: patient contain the following three conditions:
1.Sputum volume increased or Sputum properties change;2.CT Scan-Chest suggest that there was lung infection; 3.CRP and / or PCT increased
measure: 30-days Mortality
time frame: 30 days
description: dead within 30 days in ICU
measure: the Glycemic Variability(GV)
time frame: 3 days
description: Divided into three grades:I:GV less than 4mmol/24h; II 4-6mmol/24h;III more than 6mmol/24h
measure: Length of Hospital Stay (LOS)
time frame: 30 days
description: every participators stayed in hospital
arm group label: semi-solidification with nutrient
arm group type: Experimental
description: semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.
Intervention: Other: bolus Intermittent enteral feeding
arm group label: Standard enteral nutrition
arm group type: Placebo Comparator
description: After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.
Intervention: Other: Standard enteral feeding
intervention type: Dietary Supplement
intervention name: semi-solid agent with standard enteral feeding
description: after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 minutes
arm group label: semi-solidification with nutrient
other name: semi-solidification of nutrient
intervention type: Other
intervention name: standard enteral feeding
description: Intermittent enteral feeding is applied less than 60 minutes
arm group label: Standard enteral nutrition
other name: standard enteral nutrition
criteria: 
gender: All
minimum age: 14 Years
maximum age: 90 Years
healthy volunteers: No
last name: man huang, phD
role: Principal Investigator
affiliation: Second affiliated hospital, Zhejiang university school of medicine
facility: 
country: China
citation: Peev MP, Yeh DD, Quraishi SA, Osler P, Chang Y, Gillis E, Albano CE, Darak S, Velmahos GC. Causes and consequences of interrupted enteral nutrition: a prospective observational study in critically ill surgical patients. JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):21-7. doi: 10.1177/0148607114526887. Epub 2014 Apr 7.
PMID: 24714361
citation: Evans DC, Forbes R, Jones C, Cotterman R, Njoku C, Thongrong C, Tulman D, Bergese SD, Thomas S, Papadimos TJ, Stawicki SP. Continuous versus bolus tube feeds: Does the modality affect glycemic variability, tube feeding volume, caloric intake, or insulin utilization? Int J Crit Illn Inj Sci. 2016 Jan-Mar;6(1):9-15. doi: 10.4103/2229-5151.177357.
PMID: 27051616
citation: MacLeod JB, Lefton J, Houghton D, Roland C, Doherty J, Cohn SM, Barquist ES. Prospective randomized control trial of intermittent versus continuous gastric feeds for critically ill trauma patients. J Trauma. 2007 Jul;63(1):57-61. doi: 10.1097/01.ta.0000249294.58703.11.
PMID: 17622869
citation: Taylor BE, McClave SA, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society of Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Crit Care Med. 2016 Feb;44(2):390-438. doi: 10.1097/CCM.0000000000001525. No abstract available.
PMID: 26771786
citation: Logemann JA, Gensler G, Robbins J, Lindblad AS, Brandt D, Hind JA, Kosek S, Dikeman K, Kazandjian M, Gramigna GD, Lundy D, McGarvey-Toler S, Miller Gardner PJ. A randomized study of three interventions for aspiration of thin liquids in patients with dementia or Parkinson's disease. J Speech Lang Hear Res. 2008 Feb;51(1):173-83. doi: 10.1044/1092-4388(2008/013).
PMID: 18230864
citation: Bardhan KD, Strugala V, Dettmar PW. Reflux revisited: advancing the role of pepsin. Int J Otolaryngol. 2012;2012:646901. doi: 10.1155/2012/646901. Epub 2011 Nov 10.
PMID: 22242022
citation: Hayat JO, Gabieta-Somnez S, Yazaki E, Kang JY, Woodcock A, Dettmar P, Mabary J, Knowles CH, Sifrim D. Pepsin in saliva for the diagnosis of gastro-oesophageal reflux disease. Gut. 2015 Mar;64(3):373-80. doi: 10.1136/gutjnl-2014-307049. Epub 2014 May 7.
PMID: 24812000
responsible party type: Principal Investigator
investigator affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
investigator full name: Man Huang, Ph.D
investigator title: Clinical Professor
sharing ipd: No
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