<?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>IRCT2014041917026N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-04-19</date_registration>
      <primary_sponsor>Shahid sadoughi  university of medical science, Yazd</primary_sponsor>
      <public_title>Cefazolin injection in off-pump CABG</public_title>
      <acronym></acronym>
      <scientific_title>Prophylactic effect of bolus and continuous Cefazolin injection in off-pump CABG</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>141</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15764</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>Infection after cardiac surgery.</hc_freetext>
      <i_freetext>Intervention 1: In Bolus group, for patients undergoing Off- Pump Coronary Artery Bypass Graft surgery. Patients in this group received 2g of Cefazolin as a starting dose, 30 minutes before incision. Then 1g of Cefazolin were administered at 3, 11 and 19 hours after starting dose respectively .therefore, overall 5gr cefazolin administered intravenously .after surgery,we survey clinical examinations and paraclinical tests .then we follow –up patients during one month about post-operative infections. Intervention 2: In continuous group, for patients undergoing Off- Pump Coronary Artery Bypass Graft surgery. Patients in this group received 2g of Cefazolin as a starting dose, 30 minutes before incision. Then 3g of Cefazolin continuously infused during 24 hours. Therefore, overall 5gr cefazolin administered intravenously .after surgery,we survey clinical examinations and paraclinical tests .then we follow –up patients during one month about post-operative infections.</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>Seyed Khalil Forouzannia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Afshar hospital-Jomhori Blvd,yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1523 1421</telephone>
        <email>drforouzan_nia@yahoo.com</email>
        <affiliation>Shahid Sadoughi University of Medical Sciences, Yazd, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Khalil Forouzannia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Afshar hospital-Jomhori Blvd,yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1523 1421</telephone>
        <email>drforouzan_nia@yahoo.com</email>
        <affiliation>Shahid Sadoughi University of Medical Sciences, Yazd, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients without history of antibiotic therapy during the last 72 hours before surgery; no severe renal and liver failure and pregnancy; no active infection.&#13;
Exclusion criteria: all patients didn't consent to use this procedure in the study. we can't use full dose of cefazolin and excise of sign of infection during administering antibiotic.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B95.6,B95.</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other staphylococcus as the cause of diseases classified to other chapters,Staphylococcus aureus as the cause of diseases classified to other chapters</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In Bolus group, for patients undergoing Off- Pump Coronary Artery Bypass Graft surgery. Patients in this group received 2g of Cefazolin as a starting dose, 30 minutes before incision. Then 1g of Cefazolin were administered at 3, 11 and 19 hours after starting dose respectively .therefore, overall 5gr cefazolin administered intravenously .after surgery,we survey clinical examinations and paraclinical tests .then we follow –up patients during one month about post-operative infections.</i_keyword>
      <i_keyword>In continuous group, for patients undergoing Off- Pump Coronary Artery Bypass Graft surgery. Patients in this group received 2g of Cefazolin as a starting dose, 30 minutes before incision. Then 3g of Cefazolin continuously infused during 24 hours. Therefore, overall 5gr cefazolin administered intravenously .after surgery,we survey clinical examinations and paraclinical tests .then we follow –up patients during one month about post-operative infections.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Infection. Timepoint: One month. Method of measurement: Clinical evidence and paraclinical lab.</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>Shahid sadoughi  university of medical science, Yazd</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Yazd Cardiovascular Research Center, Afshar Hospital, Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Shahid Ghandi Blv- Ebne Sina Ave Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
