<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/NCT02998931</url>
  </required_header>
  <id_info>
    <org_study_id>1395/670</org_study_id>
    <nct_id>NCT02998931</nct_id>
  </id_info>
  <brief_title>Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients</brief_title>
  <official_title>Effects of Enteral Glutamine on Inflammatory Response, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shahid Beheshti University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Beheshti 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>
      Glutamine supplementation has beneficial effects on morbidity and mortality in critically ill&#xD;
      patients, possibly in part through an attenuation of the proinflammatory cytokine response&#xD;
      and a Immune function. In this trial intensive care unit patients with enteral feeding will&#xD;
      receive either enteral glutamine or maltodextrin as placebo for 28 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, double blind, controlled trial will be conducted in general intensive care unit&#xD;
      (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and&#xD;
      explanation of the risks and benefits of the study, written consent form will be completed.&#xD;
      The participants are 200 eligible hospitalized patients with enteral feeding in ICU, aged ≥&#xD;
      18 years. Intervention patients will be received 0.3 g/kg/day of glutamine along with enteral&#xD;
      formula for 28 days and control patients will be received maltodextrin along with enteral&#xD;
      formula for 28 days. Patients will be evaluated for occurrence of new infection, organ&#xD;
      failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune&#xD;
      markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 10, 2016</start_date>
  <completion_date type="Actual">September 10, 2018</completion_date>
  <primary_completion_date type="Actual">August 25, 2018</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of infection</measure>
    <time_frame>Day 28</time_frame>
    <description>Incidence of infections</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Inflammatory Markers</measure>
    <time_frame>baseline, Day 5, Day 10</time_frame>
    <description>Inflammatory factors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Immunity Markers</measure>
    <time_frame>baseline, Day 5, Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in ICU</measure>
    <time_frame>Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28-day Mortality</measure>
    <time_frame>Day 28</time_frame>
    <description>Day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-month mortality</measure>
    <time_frame>month 6</time_frame>
    <description>month 6</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Serum Glutamin</measure>
    <time_frame>baseline, Day 5, Day 10</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Critical Illness</condition>
  <condition>Enteral Nutrition</condition>
  <condition>Multiple Organ Failure</condition>
  <condition>Infection Complication</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Glutamin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glutamin</intervention_name>
    <description>Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs</description>
    <arm_group_label>Glutamin</arm_group_label>
    <other_name>L-glutamine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <description>Maltodextrin mixed with water given via NG tube Q 4 hours</description>
    <arm_group_label>maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt;18 years old) admitted to ICU&#xD;
&#xD;
          -  Start of study intervention within 48 hours after ICU admission&#xD;
&#xD;
          -  Expected to require enteral nutrition for at least 72 hours aiming for full enteral&#xD;
             nutrition and receive at least 80 percent of enteral formula during the first 48 hour&#xD;
&#xD;
          -  Written informed consent of patient or written informed consent of legal&#xD;
             representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enrollment in a related ICU interventional study&#xD;
&#xD;
          -  Requiring other specific enteral nutrition for medical reason&#xD;
&#xD;
          -  Death or Discharge before 5th day&#xD;
&#xD;
          -  Having any contra-indication to receive enteral nutrition&#xD;
&#xD;
          -  Pregnant patients or lactating with the intent to breastfeed&#xD;
&#xD;
          -  Requiring other specific enteral nutrition for medical reason&#xD;
&#xD;
          -  BMI &lt;18 or &gt; 40.0 kg/m2&#xD;
&#xD;
          -  Have life expectancy of &lt;6 mo&#xD;
&#xD;
          -  Patients who are moribond&#xD;
&#xD;
          -  Liver cirrhosis- Child's class C liver disease&#xD;
&#xD;
          -  Have seizure disorder requiring anticonvulsant&#xD;
&#xD;
          -  History of allergy or intolerance to the study product components&#xD;
&#xD;
          -  Receiving glutamine during two weeks before start study product&#xD;
&#xD;
          -  Have other reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zahra Vahdat Shariatpanahi, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shohada Tajrish Hospital</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <reference>
    <citation>van Zanten AR, Sztark F, Kaisers UX, Zielmann S, Felbinger TW, Sablotzki AR, De Waele JJ, Timsit JF, Honing ML, Keh D, Vincent JL, Zazzo JF, Fijn HB, Petit L, Preiser JC, van Horssen PJ, Hofman Z. High-protein enteral nutrition enriched with immune-modulating nutrients vs standard high-protein enteral nutrition and nosocomial infections in the ICU: a randomized clinical trial. JAMA. 2014 Aug 6;312(5):514-24. doi: 10.1001/jama.2014.7698.</citation>
    <PMID>25096691</PMID>
  </reference>
  <reference>
    <citation>Heyland D, Muscedere J, Wischmeyer PE, Cook D, Jones G, Albert M, Elke G, Berger MM, Day AG; Canadian Critical Care Trials Group. A randomized trial of glutamine and antioxidants in critically ill patients. N Engl J Med. 2013 Apr 18;368(16):1489-97. doi: 10.1056/NEJMoa1212722. Erratum In: N Engl J Med. 2013 May 9;368(19):1853. Dosage error in article text.</citation>
    <PMID>23594003</PMID>
  </reference>
  <reference>
    <citation>McClave SA, Taylor BE, 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 for 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.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available. Erratum In: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200.</citation>
    <PMID>26773077</PMID>
  </reference>
  <reference>
    <citation>Kreymann KG, Berger MM, Deutz NE, Hiesmayr M, Jolliet P, Kazandjiev G, Nitenberg G, van den Berghe G, Wernerman J; DGEM (German Society for Nutritional Medicine); Ebner C, Hartl W, Heymann C, Spies C; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Intensive care. Clin Nutr. 2006 Apr;25(2):210-23. doi: 10.1016/j.clnu.2006.01.021. Epub 2006 May 11.</citation>
    <PMID>16697087</PMID>
  </reference>
  <reference>
    <citation>McQuiggan M, Kozar R, Sailors RM, Ahn C, McKinley B, Moore F. Enteral glutamine during active shock resuscitation is safe and enhances tolerance of enteral feeding. JPEN J Parenter Enteral Nutr. 2008 Jan-Feb;32(1):28-35. doi: 10.1177/014860710803200128.</citation>
    <PMID>18165444</PMID>
  </reference>
  <reference>
    <citation>Hall JC, Dobb G, Hall J, de Sousa R, Brennan L, McCauley R. A prospective randomized trial of enteral glutamine in critical illness. Intensive Care Med. 2003 Oct;29(10):1710-6. doi: 10.1007/s00134-003-1937-2. Epub 2003 Aug 16.</citation>
    <PMID>12923621</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>October 13, 2018</last_update_submitted>
  <last_update_submitted_qc>October 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University</investigator_affiliation>
    <investigator_full_name>Zahra Vahdat Shariatpanahi</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Glutamin</keyword>
  <keyword>Enteral Nutrition</keyword>
  <keyword>Intensive Care Unit</keyword>
  <keyword>Critical Care Outcomes</keyword>
  <keyword>inflammatory</keyword>
  <keyword>Immune System</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Multiple Organ Failure</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/NCT02998931
org study id: 1395/670
nct id: NCT02998931
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Glutamine supplementation has beneficial effects on morbidity and mortality in critically ill
      patients, possibly in part through an attenuation of the proinflammatory cytokine response
      and a Immune function. In this trial intensive care unit patients with enteral feeding will
      receive either enteral glutamine or maltodextrin as placebo for 28 days.
A randomized, double blind, controlled trial will be conducted in general intensive care unit
      (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and
      explanation of the risks and benefits of the study, written consent form will be completed.
      The participants are 200 eligible hospitalized patients with enteral feeding in ICU, aged ≥
      18 years. Intervention patients will be received 0.3 g/kg/day of glutamine along with enteral
      formula for 28 days and control patients will be received maltodextrin along with enteral
      formula for 28 days. Patients will be evaluated for occurrence of new infection, organ
      failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune
      markers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Occurrence of infection
time frame: Day 28
description: Incidence of infections
measure: Serum Inflammatory Markers
time frame: baseline, Day 5, Day 10
description: Inflammatory factors
measure: Serum Immunity Markers
time frame: baseline, Day 5, Day 10
measure: Length of stay in ICU
time frame: Day 28
measure: 28-day Mortality
time frame: Day 28
description: Day 28
measure: 6-month mortality
time frame: month 6
description: month 6
measure: Serum Glutamin
time frame: baseline, Day 5, Day 10
arm group label: Glutamin
arm group type: Experimental
description: Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.
arm group label: maltodextrin
arm group type: Placebo Comparator
description: Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
intervention type: Drug
intervention name: Glutamin
description: Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs
arm group label: Glutamin
other name: L-glutamine
intervention type: Other
intervention name: Maltodextrin
description: Maltodextrin mixed with water given via NG tube Q 4 hours
arm group label: maltodextrin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zahra Vahdat Shariatpanahi, MD, PhD
role: Study Chair
affiliation: Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
facility: 
facility: 
country: Iran, Islamic Republic of
citation: van Zanten AR, Sztark F, Kaisers UX, Zielmann S, Felbinger TW, Sablotzki AR, De Waele JJ, Timsit JF, Honing ML, Keh D, Vincent JL, Zazzo JF, Fijn HB, Petit L, Preiser JC, van Horssen PJ, Hofman Z. High-protein enteral nutrition enriched with immune-modulating nutrients vs standard high-protein enteral nutrition and nosocomial infections in the ICU: a randomized clinical trial. JAMA. 2014 Aug 6;312(5):514-24. doi: 10.1001/jama.2014.7698.
PMID: 25096691
citation: Heyland D, Muscedere J, Wischmeyer PE, Cook D, Jones G, Albert M, Elke G, Berger MM, Day AG; Canadian Critical Care Trials Group. A randomized trial of glutamine and antioxidants in critically ill patients. N Engl J Med. 2013 Apr 18;368(16):1489-97. doi: 10.1056/NEJMoa1212722. Erratum In: N Engl J Med. 2013 May 9;368(19):1853. Dosage error in article text.
PMID: 23594003
citation: McClave SA, Taylor BE, 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 for 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.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available. Erratum In: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200.
PMID: 26773077
citation: Kreymann KG, Berger MM, Deutz NE, Hiesmayr M, Jolliet P, Kazandjiev G, Nitenberg G, van den Berghe G, Wernerman J; DGEM (German Society for Nutritional Medicine); Ebner C, Hartl W, Heymann C, Spies C; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Intensive care. Clin Nutr. 2006 Apr;25(2):210-23. doi: 10.1016/j.clnu.2006.01.021. Epub 2006 May 11.
PMID: 16697087
citation: McQuiggan M, Kozar R, Sailors RM, Ahn C, McKinley B, Moore F. Enteral glutamine during active shock resuscitation is safe and enhances tolerance of enteral feeding. JPEN J Parenter Enteral Nutr. 2008 Jan-Feb;32(1):28-35. doi: 10.1177/014860710803200128.
PMID: 18165444
citation: Hall JC, Dobb G, Hall J, de Sousa R, Brennan L, McCauley R. A prospective randomized trial of enteral glutamine in critical illness. Intensive Care Med. 2003 Oct;29(10):1710-6. doi: 10.1007/s00134-003-1937-2. Epub 2003 Aug 16.
PMID: 12923621
responsible party type: Principal Investigator
investigator affiliation: Shahid Beheshti University
investigator full name: Zahra Vahdat Shariatpanahi
investigator title: Associate Professor
mesh term: Inflammation
mesh term: Critical Illness
mesh term: Multiple Organ Failure
sharing ipd: Undecided