<?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>IRCT20200515047453N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-20</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparative evaluation of blood glucose changes, during surgery in children 6 months to 4 years old</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of blood glucose changes, during surgery in children 6 months to 4 years old under 1/5-4/5, ringer  and 1/3-2/3 injectable fluid</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51627</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: They are randomly distributed in three groups of 35 people using the card folding method. In this method, a number of cards or letters selected by the researcher as the first group and the same number of cards for the next second and third groups are considered; Then, by merging the cards together (flipping the cards), a card is taken out and its allocation is recorded. The cards are then merged again and another card is removed. This process continues until a random sequence is reached according to the sample size (35).</study_design>
      <phase>3</phase>
      <hc_freetext>blood glucose.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: One-fifth four-fifths, Dextrose serum 10% Ghazi 0.5 liters made in Iran and Shahid Ghazi Pharmaceutical Company, hemodynamic parameters every 15 minutes during operation and recovery and blood sugar level at baseline with blood sample, every hour during operation and end of operation with glucometer and 2 hours After surgery with blood sample, electrolyte is measured before and 2 hours after surgery, blood acidity is measured and recorded at 2 hours postoperatively through ABG and urinary output at the end of surgery and at the end of recovery and 2 hours after surgery. Intervention 2: Intervention group: One third two thirds, Dextrose serum 10% Ghazi 0.5 liters made in Iran and Shahid Ghazi Pharmaceutical Company, hemodynamic parameters every 15 minutes during operation and recovery and blood sugar level at baseline with blood sample, every hour during operation and end of operation with glucometer and 2 hours After surgery with blood sample, electrolyte is measured before and 2 hours after surgery, blood acidity is measured and recorded at 2 hours postoperatively through ABG and urinary output at the end of surgery and at the end of recovery and 2 hours after surgery. Intervention 3: Intervention group: Ringer, Ringer Lactate Serum 10% Ghazi 0.5 liters Made in Iran and Shahid Ghazi Pharmaceutical Company, Hemodynamic parameters every 15 minutes during surgery and recovery and blood sugar level at baseline with blood sample, every hour during surgery and end of operation with glucometer and 2 Postoperative saturation with blood sample, electrolyte before and 2 hours after surgery, blood acidity at 2 hours postoperatively through ABG and urinary output at the end of surgery and at the end of recovery and 2 hours after surgery are recorded.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Some of the information can be shared

When:
4 months after printing the results

To whom:
All researchers

Conditions:
No analysis will be allowed

Where to obtain:
Email address

How to obtain:
Request by e-mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parvin Sajedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib Ave,</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8739118631</zip>
        <telephone>+98 31 5550 0111</telephone>
        <email>sajedi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvin Sajedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib Ave,</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8739118631</zip>
        <telephone>+98 31 5550 0111</telephone>
        <email>sajedi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 6 months to 4 years
Consent of the patient's parents to participate in the study
ASA=1,2
Candidate for surgery under general anesthesia</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>4 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient with type 1 diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R73.09</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other abnormal glucose</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: One-fifth four-fifths, Dextrose serum 10% Ghazi 0.5 liters made in Iran and Shahid Ghazi Pharmaceutical Company, hemodynamic parameters every 15 minutes during operation and recovery and blood sugar level at baseline with blood sample, every hour during operation and end of operation with glucometer and 2 hours After surgery with blood sample, electrolyte is measured before and 2 hours after surgery, blood acidity is measured and recorded at 2 hours postoperatively through ABG and urinary output at the end of surgery and at the end of recovery and 2 hours after surgery.</i_keyword>
      <i_keyword>Intervention group: One third two thirds, Dextrose serum 10% Ghazi 0.5 liters made in Iran and Shahid Ghazi Pharmaceutical Company, hemodynamic parameters every 15 minutes during operation and recovery and blood sugar level at baseline with blood sample, every hour during operation and end of operation with glucometer and 2 hours After surgery with blood sample, electrolyte is measured before and 2 hours after surgery, blood acidity is measured and recorded at 2 hours postoperatively through ABG and urinary output at the end of surgery and at the end of recovery and 2 hours after surgery.</i_keyword>
      <i_keyword>Intervention group: Ringer, Ringer Lactate Serum 10% Ghazi 0.5 liters Made in Iran and Shahid Ghazi Pharmaceutical Company, Hemodynamic parameters every 15 minutes during surgery and recovery and blood sugar level at baseline with blood sample, every hour during surgery and end of operation with glucometer and 2 Postoperative saturation with blood sample, electrolyte before and 2 hours after surgery, blood acidity at 2 hours postoperatively through ABG and urinary output at the end of surgery and at the end of recovery and 2 hours after surgery are recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood sugar level. Timepoint: Hemodynamic parameters are measured and recorded every 15 minutes during surgery and recovery and blood sugar levels at baseline and every one hour during surgery and 2 hours after surgery. Method of measurement: Glucometer, ABG.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-30</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical science-Hezar Jarib Avenue,  Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
