<?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>IRCT2015072311399N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-04</date_registration>
      <primary_sponsor>Vice chancellor for research, Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The Comparison of the effects of metformin and insulin in the treatment of hyperglycemia</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison of the effects of metformin and insulin in the treatment of hyperglycemia after coronary artery bypass surgery in non diabetic patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11672</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Hyperglycemia after coronary artery bypass surgery. Condition 2: Hyperglycaemia.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group (1) or insulin group, patients will receive continuous insulin infusion according to the protocol of STS.After starting insulin infusion ,these patients’ blood glucose will be controlled per hour and according to their blood glucose level, the amount of insulin infusion will be continued.In this group blood glucose control interval will be every six hours after the stabilization of blood glucose. Then insulin infusion and six-hour blood glucose control will continue until the end of the third postoperative day (72 hours). Intervention 2: In the intervention group (2) or metformin group, the patients will receive metformin 500 mg twice a day and before the next dose of metformin, their blood glucose will be evaluated. If lactate is higher than 4/5 or 2 mmol higher than the previous response, takingmetformin will be stopped and the patient will be excluded.In these patients after starting metformintablet, their blood glucose will be controlled per hour and it will continue until the stabilization of blood glucose level.In this group the blood glucose interval control will be every six hours after the stabilization of blood glucose. Then, the prescription of metformin tablet of a dose of 500 mg twice a day and six-hour control of blood glucose until the end of the third postoperative day (72 hours) will continue.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas-Ali Ebrahimian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room #120, 1th floor, School of Nursing and Allied Health Sciences, Semnan University of medical Sciences, Km5 Damghan Road</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3365 4191</telephone>
        <email>aa.ebrahimian@semums.ac.irebrahimian.aa@gmail.com</email>
        <affiliation>Semnan University of medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kamran Ghods</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosae Hospital- basij Blvd</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3343 7825</telephone>
        <email>k.ghods@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Glycosylated hemoglobin less than 7%; Blood glucose above 150 mg/dl; Elective coronary artery bypass surgery; Age between 35 to 75 years old; The use of cardiopulmonary bypass; Hemodynamically stable(BP&gt;70 mmHg and PR between 50 and 110).&#13;
Exclusion criteria: History of diabetes; GFR less than 60%; life-threatening arrhythmias; Prolonged intubation; The use of inotropic agents for hemodynamic stability; Potassium level higher than 5.5 or less than 3.5 on admission in ICU; Metabolic acidosis lower than 7.25 or lactate level higher than 4.5 mg/dl or BE less than 6 mmo/L; Pao 2 less than 60 mm Hg; The patient is NPO</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>197.1</hc_code>
      <hc_code>R73.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other functional disturbances following cardiac surgery</hc_keyword>
      <hc_keyword>Hyperglycaemia, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group (1) or insulin group, patients will receive continuous insulin infusion according to the protocol of STS.After starting insulin infusion ,these patients’ blood glucose will be controlled per hour and according to their blood glucose level, the amount of insulin infusion will be continued.In this group blood glucose control interval will be every six hours after the stabilization of blood glucose. Then insulin infusion and six-hour blood glucose control will continue until the end of the third postoperative day (72 hours).</i_keyword>
      <i_keyword>In the intervention group (2) or metformin group, the patients will receive metformin 500 mg twice a day and before the next dose of metformin, their blood glucose will be evaluated. If lactate is higher than 4/5 or 2 mmol higher than the previous response, takingmetformin will be stopped and the patient will be excluded.In these patients after starting metformintablet, their blood glucose will be controlled per hour and it will continue until the stabilization of blood glucose level.In this group the blood glucose interval control will be every six hours after the stabilization of blood glucose. Then, the prescription of metformin tablet of a dose of 500 mg twice a day and six-hour control of blood glucose until the end of the third postoperative day (72 hours) will continue.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Suger. Timepoint: Up to 6 hours after surgery each time and then every 6 hours. Method of measurement: Glucometer device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lactat. Timepoint: Q 12 Hr. Method of measurement: Using of ABG machine.</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>Vice chancellor for research, Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-28</approval_date>
        <contact_name>Ethic committee of Semnan University Of Medical sience</contact_name>
        <contact_address>Vice chancellor for research, Semnan University of Medical Sciences, Basij Blvd Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
