<?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>IRCT20151226025699N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-03</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of parenteral nutrition on ICU patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of personalized parenteral nutrition on Intensive care unit   (ICU) patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36823</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients of ICU are assigned to the intervention and control groups through simple individualized randomization by  online software (randomizer.org), Blinding description: The subjects (both the case and control groups) are blinded to intervention assignment. Also, nurses who assess and collect data on outcome, are blinded to groups' assignment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gastrointestinal hemorrhage.</hc_freetext>
      <i_freetext>Intervention 1: After the gain of real weight and evaluation of disease status and chemistry results, the amount of required calorie will be estimated according to the ASPEN guidelines and then, the appropriate diet will be designed. We avoid to feeding the lipid in the first of hospitalization. The required protein will be calculated according to the patient's status and determined by the required percent of amino acids and Dextrose. We also will use the daily relevant vials for providing the vitamins and required minerals. Finally, we will insert the diet with relevant advises in to the conference form and deliver to the relevant specialist doctor for final acceptance. Intervention 2: Control group will daily receive low calorie of parenteral diet, including 800 to 1000 calories according to the hospital's routine. We usually administer Dextrose every day, which provide 70% of patient's calorie and administer Aminoven or Intralipid every other day, which provide 30% of patient's calorie. All of measurements repeated after one week.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more data is available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pr. Mohammad Esmaeil Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Tajrish square,  Tajrish martys hospital,Cancer research center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>021 22748001-2</telephone>
        <email>me-akbari@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Saeid Doaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardare Jangal Boulevard</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41448</zip>
        <telephone>+98 13 3355 0028</telephone>
        <email>sdoaei@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent to participation
Need to parenteral nutrition
At least 24-h of hospitalization</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having no indication for parenteral nutrition for more than 1 week
Unstable hemodynamic conditions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K92.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gastrointestinal hemorrhage, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After the gain of real weight and evaluation of disease status and chemistry results, the amount of required calorie will be estimated according to the ASPEN guidelines and then, the appropriate diet will be designed. We avoid to feeding the lipid in the first of hospitalization. The required protein will be calculated according to the patient's status and determined by the required percent of amino acids and Dextrose. We also will use the daily relevant vials for providing the vitamins and required minerals. Finally, we will insert the diet with relevant advises in to the conference form and deliver to the relevant specialist doctor for final acceptance.</i_keyword>
      <i_keyword>Control group will daily receive low calorie of parenteral diet, including 800 to 1000 calories according to the hospital's routine. We usually administer Dextrose every day, which provide 70% of patient's calorie and administer Aminoven or Intralipid every other day, which provide 30% of patient's calorie. All of measurements repeated after one week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Urea. Timepoint: Baseline, 14-day after intervention. Method of measurement: using standard kits and the researchers gather these information from the lab test section of the ICU sheets.</prim_outcome>
      <prim_outcome>Creatinine. Timepoint: Baseline, 14-day after intervention. Method of measurement: using standard kits and the researchers gather these information from the lab test section of the ICU sheets.</prim_outcome>
      <prim_outcome>C reactive protein (CRP). Timepoint: Baseline, 14-day after intervention. Method of measurement: using standard kits and the researchers gather these information from the lab test section of the ICU sheets.</prim_outcome>
      <prim_outcome>Serum albumin. Timepoint: Baseline, 14-day after intervention. Method of measurement: using standard kits and the researchers gather these information from the lab test section of the ICU sheets.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>ICU hospitalization. Timepoint: Baseline, 14-day after intervention. Method of measurement: Patients documents.</sec_outcome>
      <sec_outcome>Survival rate. Timepoint: During 14-day intervention. Method of measurement: Patients documents.</sec_outcome>
      <sec_outcome>Weight. Timepoint: During 14-day intervention. Method of measurement: This anthropometric indicator will be gathered from the patients records.</sec_outcome>
      <sec_outcome>Body mass index (BMI). Timepoint: During 14-day intervention. Method of measurement: This anthropometric indicator will be gathered from the patients records.</sec_outcome>
      <sec_outcome>Malnutrition status. Timepoint: During 14-day intervention. Method of measurement: It will be evaluated by weight &amp; BMI criteria and by the level of serum albumin. We also use the Nutritional Risk Screening (NRS 2002) criterion for more evaluation.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Rasht University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
      <source_name>Rasht university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-12</approval_date>
        <contact_name>Cancer research center of Shahid beheshti University of Medical Sciences</contact_name>
        <contact_address>Tehran, Tajrish square,  Tajrish martys hospital,Cancer research center Tajrish Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
