<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20120525009856N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-26</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of calorie intake on Intensive Care Unite patients</public_title>
      <acronym></acronym>
      <scientific_title>comparative clinical outcome in Hypocaloric vs. Fullcaloric Enteral feeding during the first week of Hospitalization in Intensive Care Unite Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28712</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients will be divided into two groups of hypocaloric and full-calorie diet by using Stratified blocked randomization, so that two groups will not have a significant difference in terms of gender, age, body mass index and severity of illness, Blinding description: Double-blinded method will be used in order to prevent incidence of information bias, in such a way that after calculating required energy for patient, a code will be given to the subject. Afterwards, the patient will be enter into one of the two groups of intervention and control group, based on the attained code through randomized classified method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients of intensive care unit.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group will receive Hypocaloric diet. After hemodynamic stabilization, enteral nutrition support will be started during the first 24-48 hours that individual will be inpatient, and will be prescribed in form of bolus every three hours (6 times in 24 hours). Subjects of hypocaloric diet group will receive 40 percent of calculated calorie by using indirect calorimetry device during the first 24-48 hours of being in patient, and this amount will be reach to100 percent of patient’s need in one week. This group will be fed exactly similar to control group by full-calorie method after 7 days of intervention. Intervention 2: Patients of first group that defined as control group, which is the full-calorie group, will receive 80 to 100 percent of their actual energy requirement as nutrition support in form of enteral method that will be started during the first 24-48 hours of being inpatient. The required calorie will be calculated through indirect calorimetry and intervention will be continued for 7 days.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyede Zeinab Mousavian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Public Health faculty, Next to the Farabi Hospital, Dolat Ababd blvd, Isar Square, Imam Hosein Exp</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851351</zip>
        <telephone>+91 83382 81991</telephone>
        <email>sz.mousavian@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Yahya Pasdar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Public Health faculty, Next to the Farabi Hospital, Dolat Ababd blvd, Isar Square, Imam Hosein Exp</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 1826 2005</telephone>
        <email>yahya.pasdar@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with expected length of hospitalization in Intensive Care Unite for at least 94 hours
adult patients, 18 to 65 y old
cannot eat sufficiently</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>body mass index (BMI)  less than 18.5
mechanical ventilation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in the intervention group will receive Hypocaloric diet. After hemodynamic stabilization, enteral nutrition support will be started during the first 24-48 hours that individual will be inpatient, and will be prescribed in form of bolus every three hours (6 times in 24 hours). Subjects of hypocaloric diet group will receive 40 percent of calculated calorie by using indirect calorimetry device during the first 24-48 hours of being in patient, and this amount will be reach to100 percent of patient’s need in one week. This group will be fed exactly similar to control group by full-calorie method after 7 days of intervention.</i_keyword>
      <i_keyword>Patients of first group that defined as control group, which is the full-calorie group, will receive 80 to 100 percent of their actual energy requirement as nutrition support in form of enteral method that will be started during the first 24-48 hours of being inpatient. The required calorie will be calculated through indirect calorimetry and intervention will be continued for 7 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aspartate amino transferase. Timepoint: Before intervention, after intervention and one week after intervention. Method of measurement: Spectrophotometer.</prim_outcome>
      <prim_outcome>Alanine amino transferase. Timepoint: Before intervention, after intervention and one week after intervention. Method of measurement: Spectrophotometer.</prim_outcome>
      <prim_outcome>Reactive Protein C. Timepoint: Before intervention, after intervention and one week after intervention. Method of measurement: Autoanalyser.</prim_outcome>
      <prim_outcome>High density lipoprotein. Timepoint: Before intervention, after intervention and one week after intervention. Method of measurement: HDL kit.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before intervention, after intervention and one week after intervention. Method of measurement: kit TG.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Before intervention, after intervention and one week after intervention. Method of measurement: Cholesterol Kit.</prim_outcome>
      <prim_outcome>Low density lipoprotein. Timepoint: Before intervention, after intervention and one week after intervention. Method of measurement: Calculate with Friedewald formula.</prim_outcome>
      <prim_outcome>Evaluation of electrolytes (sodium, potassium, magnesium, phosphorus). Timepoint: Before intervention, after intervention and one week after intervention. Method of measurement: Electrolyte analyzer.</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Every day for two weeks. Method of measurement: Avtanalizer device.</prim_outcome>
      <prim_outcome>Multinational defect. Timepoint: Time intervals 24, 48, 96 hours and the end of intervention. Method of measurement: Sofa questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insulin received. Timepoint: Every day for two weeks. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Infection rate. Timepoint: Followed for 28 days. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Duration of ventilator dependence. Timepoint: Followed for 28 days. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Mortality. Timepoint: Followed for 28 days. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Number of hospital admissions days in the intensive care unit. Timepoint: Followed for 28 days. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Number of hospital admissions days. Timepoint: Followed for 28 days. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Digestive complications. Timepoint: Every day for two weeks. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Gastrointestinal intolerance. Timepoint: Every day for two weeks. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Calorie intake. Timepoint: Every day for two weeks. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Percentage of protein intake. Timepoint: Every day for two weeks. Method of measurement: questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-14</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology, Building No. 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti blvd Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
