<?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>IRCT2015050311712N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-10-30</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Integrated measuring blood glucose in diabetic patients undergoing open heart surgery</public_title>
      <acronym></acronym>
      <scientific_title>Impact of consistent measurement and management of blood glucose on clinical outcomes in patients with type 2 diabetes undergoing coronary artery bypass surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11896</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: Diabetes Mellitus. Condition 2: Other specified complications of cardiac and vascular prosthetic devices, implants and grafts.</hc_freetext>
      <i_freetext>Intervention 1: Control group: this group will be undergone insulin protocol common at hospital since entering into the unit until releasing time by regular insulin subcutaneous injection in surgery unit and intensive care unit every 6 hour and  venous continuous infusion in intensive care unit  and secondary variables will be studied. Intervention 2: Test group: this group will be undergone a revised new protocol of insulin since entering into the unit until releasing time by regular subcutaneous insulin injection in surgery unit and intensive care unit every 6 hour and venous continuous infusion in intensive care unit and secondary variables will be studied.</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>Zahra Rahnavard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Of Nursing And Midwifery Of Tehran, Dr. Mir khani St., Tohid Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>z.rahnavard@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naiyereh Pishnamaz Ahari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Of Nursing And Midwifery Of Tehran, Dr. Mir khani St., Tohid Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 66927171</telephone>
        <email>yeganeh33@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria were; Patients who underwent elective coronary artery bypass surgery and the first time (with on  pump or off pump) , who the day before surgery were be hospitalized; Patients who have type 2 diabetes diagnosed during hospitalization or admission to the hospital by  blood sugar test, blood sugar after a meal and a diagnosis of type 2 diabetes after  glucose tolerance ; patients who did not have other heart disease exception  of coronary artery disease; patients with a creatinine level less than 2, patients who did not  have kidney disease; not having another heart attack or another heart surgery at same time; no previous heart surgery; positive history of past severe disease; on-emergency surgery; non-cytotoxic drugs and radiation use.Exclusion criteria were; the operation of the on pump switch to off pump; addition of other surgery such as surgery aneurysmectomy LV; performed endarterctomy on the involved vessels; unwillingness to continuing  research, patient died during the study.The number of sample size based on other studies has been determined 50. Before the surgery all of the patients in both groups were inform about the benefits of this research and then if they signed the consent form will continue in the study. Patients were assured that any time they can come out of research.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10,E11,E1</hc_code>
      <hc_code>I25.1,T82.</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes Mellitus</hc_keyword>
      <hc_keyword>T82.8 Other specified complications of cardiac and vascular prosthetic devices, implants and grafts, I25.1 coronary (artery) desease</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>Control group: this group will be undergone insulin protocol common at hospital since entering into the unit until releasing time by regular insulin subcutaneous injection in surgery unit and intensive care unit every 6 hour and  venous continuous infusion in intensive care unit  and secondary variables will be studied.</i_keyword>
      <i_keyword>Test group: this group will be undergone a revised new protocol of insulin since entering into the unit until releasing time by regular subcutaneous insulin injection in surgery unit and intensive care unit every 6 hour and venous continuous infusion in intensive care unit and secondary variables will be studied.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Glucos. Timepoint: Three time every six hour before surgery and every one hour due to surgery and after surgery in ICU and every six hour after surgery in ward till discharge. Method of measurement: The level of serum.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Creatinin. Timepoint: One time befor surgery and three time after surgery. Method of measurement: The level of serum.</sec_outcome>
      <sec_outcome>Hospitalization days. Timepoint: Until discharge from the hospital. Method of measurement: Observations and patient file.</sec_outcome>
      <sec_outcome>Health costs. Timepoint: At the end of the study. Method of measurement: Health costs form.</sec_outcome>
      <sec_outcome>Surgical site infection. Timepoint: Beginning of study on the first, second, third, fourth and fifth after operation. Method of measurement: According fever and purulent discharge from the surgical site.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shahid Madani Cardiovascular Research Center</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
      <source_name>Shahid Madani Cardiovascular Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-07-20</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences- Enqelab Street- Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
