<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/NCT04479254</url>
  </required_header>
  <id_info>
    <org_study_id>2019-504/14/11/2</org_study_id>
    <nct_id>NCT04479254</nct_id>
  </id_info>
  <brief_title>The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)</brief_title>
  <official_title>The Impact of Indirect Calorimetry Guided Medical Feeding Protocol on Clinical Outcomes in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Islamic University Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International Islamic University Malaysia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adequate nutritional support is an essential element for achieving favourable outcomes in&#xD;
      critically ill patients. Therefore, an accurate determination of patients' energy needs is&#xD;
      required to optimize nutritional support and reduce the harmful effects of under- and&#xD;
      over-feeding. Currently, indirect calorimetry is considered as a gold standard for measuring&#xD;
      energy expenditure during critical illness.&#xD;
&#xD;
      This randomized study aims to investigate the impact of indirect calorimetry guided nutrition&#xD;
      therapy on clinical outcomes such as ICU. Mortality, hospital mortality, duration of&#xD;
      mechanical ventilation, length of I.C.U./hospital stay and mascle wasting. The investigators&#xD;
      hypothesis that nutrition therapy guided by IC will improve clinical outcomes in severely ill&#xD;
      patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-blind randomized control study. Eligible participants are randomly assigned&#xD;
      within 24 hrs of ICU. admission in two groups&#xD;
&#xD;
        -  Intervention group: The calorie needs will be determined by indirect calorimetry.&#xD;
&#xD;
        -  Control group: a routine standard weight-based equation (20-25kcal/kg ideal body&#xD;
           weight/day) will be used to estimate the energy requirements of critically ill patients.&#xD;
&#xD;
      Daily energy and protein data will be recorded for a maximum of 12 evaluable days&#xD;
      (nutritional days) or until death or discharge from ICU.while outcome data will be collected&#xD;
      for a maximum of 28 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2019</start_date>
  <completion_date type="Actual">September 25, 2020</completion_date>
  <primary_completion_date type="Actual">August 25, 2020</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>28 Days</time_frame>
    <description>Rate of mortality from all causes before or at day 28 in the ICU during the same ICU admission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>28 Days</time_frame>
    <description>will be measured as the number of calendar days between admission and discharge from ICU.or until 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of mechanical ventilation</measure>
    <time_frame>28Days</time_frame>
    <description>will be measured as the calendar days between start and end of mechanical ventilation until 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length hospital stay</measure>
    <time_frame>28 Days</time_frame>
    <description>will be calculated using the admission date and expiration or discharge date from hospital until 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>28Days</time_frame>
    <description>Rate of mortality from all causes (death in ICU or in ward) before or at day 28 during the same hospital admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle wasting</measure>
    <time_frame>First 10 days of ICU admission</time_frame>
    <description>define as differences between the serial ultrasound measurement of quadriceps femoris muscle layer thickness (vastus intermedius and rectus femoris) over the first 10 days(on day 1,3,5,7 and 10 ) of ICU Admission.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Indirect Calorimetry- Directed Nutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enteral Nutrition (EN) will be the preferred route of nutrition, and will be initiated within the first 24-48 hours of ICU admission. Caloric requirements will be measured by indirect calorimetry IC as soon as possible after recruitment and will be repeated in every 24 hrs. The amount of delivery is gradually increased to avoid the possibility of gastrointestinal intolerance. If EN fails to reach caloric goals or not feasible supplementary Parenteral nutrition(PN) will be initiated after 5-7days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard weight-based equation- Directed Nutrition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Enteral Nutrition (EN) will be initiated within the first 24-48 hours of ICU. Admission. Enteral nutrient delivery is gradually increased to avoid the possibility of gastrointestinal intolerance so that a few days are required to achieve the caloric target. PN will be started after 5-7 days if EN is not feasible. Energy and protein goals will be calculated by the standard weight-based equation of 25 kcal/kg BW body weight and 1.2-2.5 g/kg body weight, respectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)</intervention_name>
    <description>Enteral nutrition feeding formula is used in powder form and will be reconstituted by attending nurses, Continuous feeding is commonly used which will be prescribed by the attending clinicians, Energy and protein intake from EN will be estimated by multiplying the volume of feed given to energy (kcal) and protein (g) in 1 ml of standard dilution, and for Standard PN product, energy and protein intake will also be calculated based on the volume infused.</description>
    <arm_group_label>Indirect Calorimetry- Directed Nutrition</arm_group_label>
    <arm_group_label>Standard weight-based equation- Directed Nutrition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients aged over 18 years old&#xD;
&#xD;
          -  Critically ill patients with me ical ventilation&#xD;
&#xD;
          -  Expected to have an ICU. stay of more than (3) days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requirement for inspired oxygen content (FiO2) greater than 0.6&#xD;
&#xD;
          -  Patients on high-frequency ventilation&#xD;
&#xD;
          -  Patients with chest tubes that leak air/ Bronchopleural fistula&#xD;
&#xD;
          -  Patients with incompetent tracheal cuff&#xD;
&#xD;
          -  Patients inhaled nitric oxide therapy&#xD;
&#xD;
          -  Patients receiving continuous renal replacement therapy (CRRT) during IC measurement&#xD;
&#xD;
          -  Patients with pregnancy&#xD;
&#xD;
          -  Patients with burn injury&#xD;
&#xD;
          -  Patients infected with human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Patients with severe liver disease (Child-Pugh score C)&#xD;
&#xD;
          -  seizure activity&#xD;
&#xD;
          -  patients suffering from significant head trauma (GCS &lt;8)&#xD;
&#xD;
          -  Patients with paraplegia and quadriplegia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>DR. MOHD BASRI Mat Nor, M.Med (Anesthesiology)</last_name>
    <role>Principal Investigator</role>
    <affiliation>IIUM University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IIUM- Medical Center</name>
      <address>
        <city>Kuantan</city>
        <state>Pahang</state>
        <zip>25200</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <reference>
    <citation>Singer P, Anbar R, Cohen J, Shapiro H, Shalita-Chesner M, Lev S, Grozovski E, Theilla M, Frishman S, Madar Z. The tight calorie control study (TICACOS): a prospective, randomized, controlled pilot study of nutritional support in critically ill patients. Intensive Care Med. 2011 Apr;37(4):601-9. doi: 10.1007/s00134-011-2146-z. Epub 2011 Feb 22.</citation>
    <PMID>21340655</PMID>
  </reference>
  <reference>
    <citation>Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Jensen TH, Lange T, Perner A. Early goal-directed nutrition in ICU patients (EAT-ICU): protocol for a randomised trial. Dan Med J. 2016 Sep;63(9):A5271.</citation>
    <PMID>27585532</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>August 27, 2021</last_update_submitted>
  <last_update_submitted_qc>August 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>International Islamic University Malaysia</investigator_affiliation>
    <investigator_full_name>Mohd Basri Mat Nor</investigator_full_name>
    <investigator_title>Associate.Professor</investigator_title>
  </responsible_party>
  <keyword>Indirect calorimetry, Energy expenditure, Critical illness</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/NCT04479254
org study id: 2019-504/14/11/2
nct id: NCT04479254
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Adequate nutritional support is an essential element for achieving favourable outcomes in
      critically ill patients. Therefore, an accurate determination of patients' energy needs is
      required to optimize nutritional support and reduce the harmful effects of under- and
      over-feeding. Currently, indirect calorimetry is considered as a gold standard for measuring
      energy expenditure during critical illness.

      This randomized study aims to investigate the impact of indirect calorimetry guided nutrition
      therapy on clinical outcomes such as ICU. Mortality, hospital mortality, duration of
      mechanical ventilation, length of I.C.U./hospital stay and mascle wasting. The investigators
      hypothesis that nutrition therapy guided by IC will improve clinical outcomes in severely ill
      patients
This is a single-blind randomized control study. Eligible participants are randomly assigned
      within 24 hrs of ICU. admission in two groups

        -  Intervention group: The calorie needs will be determined by indirect calorimetry.

        -  Control group: a routine standard weight-based equation (20-25kcal/kg ideal body
           weight/day) will be used to estimate the energy requirements of critically ill patients.

      Daily energy and protein data will be recorded for a maximum of 12 evaluable days
      (nutritional days) or until death or discharge from ICU.while outcome data will be collected
      for a maximum of 28 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: ICU mortality
time frame: 28 Days
description: Rate of mortality from all causes before or at day 28 in the ICU during the same ICU admission
measure: Length of ICU stay
time frame: 28 Days
description: will be measured as the number of calendar days between admission and discharge from ICU.or until 28 days
measure: Length of mechanical ventilation
time frame: 28Days
description: will be measured as the calendar days between start and end of mechanical ventilation until 28 days
measure: Length hospital stay
time frame: 28 Days
description: will be calculated using the admission date and expiration or discharge date from hospital until 28 days
measure: Hospital mortality
time frame: 28Days
description: Rate of mortality from all causes (death in ICU or in ward) before or at day 28 during the same hospital admission.
measure: Muscle wasting
time frame: First 10 days of ICU admission
description: define as differences between the serial ultrasound measurement of quadriceps femoris muscle layer thickness (vastus intermedius and rectus femoris) over the first 10 days(on day 1,3,5,7 and 10 ) of ICU Admission.
arm group label: Indirect Calorimetry- Directed Nutrition
arm group type: Experimental
description: Enteral Nutrition (EN) will be the preferred route of nutrition, and will be initiated within the first 24-48 hours of ICU admission. Caloric requirements will be measured by indirect calorimetry IC as soon as possible after recruitment and will be repeated in every 24 hrs. The amount of delivery is gradually increased to avoid the possibility of gastrointestinal intolerance. If EN fails to reach caloric goals or not feasible supplementary Parenteral nutrition(PN) will be initiated after 5-7days
arm group label: Standard weight-based equation- Directed Nutrition
arm group type: Active Comparator
description: Enteral Nutrition (EN) will be initiated within the first 24-48 hours of ICU. Admission. Enteral nutrient delivery is gradually increased to avoid the possibility of gastrointestinal intolerance so that a few days are required to achieve the caloric target. PN will be started after 5-7 days if EN is not feasible. Energy and protein goals will be calculated by the standard weight-based equation of 25 kcal/kg BW body weight and 1.2-2.5 g/kg body weight, respectively.
intervention type: Dietary Supplement
intervention name: Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)
description: Enteral nutrition feeding formula is used in powder form and will be reconstituted by attending nurses, Continuous feeding is commonly used which will be prescribed by the attending clinicians, Energy and protein intake from EN will be estimated by multiplying the volume of feed given to energy (kcal) and protein (g) in 1 ml of standard dilution, and for Standard PN product, energy and protein intake will also be calculated based on the volume infused.
arm group label: Indirect Calorimetry- Directed Nutrition
arm group label: Standard weight-based equation- Directed Nutrition
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: DR. MOHD BASRI Mat Nor, M.Med (Anesthesiology)
role: Principal Investigator
affiliation: IIUM University
facility: 
country: Malaysia
citation: Singer P, Anbar R, Cohen J, Shapiro H, Shalita-Chesner M, Lev S, Grozovski E, Theilla M, Frishman S, Madar Z. The tight calorie control study (TICACOS): a prospective, randomized, controlled pilot study of nutritional support in critically ill patients. Intensive Care Med. 2011 Apr;37(4):601-9. doi: 10.1007/s00134-011-2146-z. Epub 2011 Feb 22.
PMID: 21340655
citation: Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Jensen TH, Lange T, Perner A. Early goal-directed nutrition in ICU patients (EAT-ICU): protocol for a randomised trial. Dan Med J. 2016 Sep;63(9):A5271.
PMID: 27585532
responsible party type: Principal Investigator
investigator affiliation: International Islamic University Malaysia
investigator full name: Mohd Basri Mat Nor
investigator title: Associate.Professor
mesh term: Critical Illness
sharing ipd: Undecided