<?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>IRCT2014090813156N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-12-30</date_registration>
      <primary_sponsor>Research Centre of Mazandaran Univeristy of Medical Sciences</primary_sponsor>
      <public_title>Effect of amiodarone in postoperative atrial fibrillation after coronary artery bypass surgery</public_title>
      <acronym>amiodarone</acronym>
      <scientific_title>Effect of prophylactic amiodarone in the prevention of postoperative atrial fibrillation after coronary artery bypass surgery in Mazandaran Heart Center</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13083</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>CAD in CABG.</hc_freetext>
      <i_freetext>Intervention 1: Control group: in this group use placebo (structured by normal saline serum) that similiar to Amiodarone Ampules and tablets. according to this research, anesthesia and patient do not inform about infusion, so two blind research have. in OR; two times infuse placebo and after that in ICU ward infuse drip in 24 hrs, then oral placebo are fed until discharge.        &#13;
Preoperative and Postoperative atrial size and ejection fraction measured. Intervention 2: Amiodarone: Amiodarone vial 2 vials 2 ml ampoules equivalent to 300 mg amiodarone, the surgical incision during a time period of 20 minutes through a central venous catheter, and the next dose as DrIp ICUOH within 24 hours by weight will receive 20 mg per kg. &#13;
Preoperative and Postoperative atrial size and ejection fraction measured.</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>Kaveh Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh nursing School, Vesal street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 911 780 7886</telephone>
        <email>kavehjafari@yahoo.com</email>
        <affiliation>Mazandaran University of Medial Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kaveh Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh Nursing School, Vesal Street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 911 780 7886</telephone>
        <email>kavehjafari@yahoo.com</email>
        <affiliation>Mazandaran University of Medial Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criterion: preoperative sinus rhythm.&#13;
 Exclusion criteria: allergy to amiodarone or use of amiodarone in the last 6 months; history of toxicity with amiodarone, anti-arrhythmic therapy before surgery; thyroid disease; aspartate aminotransferase or alanine aminotransferase concentration 4 times higher than normal; pregnant patients, a lower rate 50; heart failure; AV block and surgical history of lung disease and hepatitis.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T82.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mechanical complication of coronary artery bypass and valve grafts</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: in this group use placebo (structured by normal saline serum) that similiar to Amiodarone Ampules and tablets. according to this research, anesthesia and patient do not inform about infusion, so two blind research have. in OR; two times infuse placebo and after that in ICU ward infuse drip in 24 hrs, then oral placebo are fed until discharge.        &#13;
Preoperative and Postoperative atrial size and ejection fraction measured</i_keyword>
      <i_keyword>Amiodarone: Amiodarone vial 2 vials 2 ml ampoules equivalent to 300 mg amiodarone, the surgical incision during a time period of 20 minutes through a central venous catheter, and the next dose as DrIp ICUOH within 24 hours by weight will receive 20 mg per kg. &#13;
Preoperative and Postoperative atrial size and ejection fraction measured</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The incidence of atrial fibrillation. Timepoint: During hospitalization. Method of measurement: Monitoring.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hospitalization time. Timepoint: During hospitalization. Method of measurement: Monitoring and documentation.</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>Research Centre of Mazandaran Univeristy of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-19</approval_date>
        <contact_name>Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor foe research, Mazandaran University of Medical Sciences Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
