<?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>IRCT2012100611013N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-26</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of N-acetylcysteine plus carvedilol, with carvedilol alone, in the prevention of atrial fibrillation after open heart surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of N-acetylcysteine plus carvedilol, with carvedilol alone, in the prevention of atrial fibrillation after open heart surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11375</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Atrial Fibrillation.</hc_freetext>
      <i_freetext>Intervention 1: Case group:All of patients who are candidated for open heart surgery and didn't have contraindication for Beta blocker underwent premedication with oral carvedilol with doses 6.25 mg twice days for 3 days before open heart surgery, In these patients, at the time of initiation of cardiopulmonary bypass and when using a cardiopulmonary solution for cardiac arrest, n-acetylcysteine at a rate of 4 milimole per liter (50 mg / kg) was added to the second cardioplegic solution in a single dose, and Eventually, the solution is used during the operation on the heart tissue.and they are monitored for five days in the intensive care unit. Intervention 2: Control group:All of patients who are candidated for open heart surgery and didn't have contraindication for Beta blocker underwent premedication with oral carvedilol with doses 6.25 mg twice days for 3 days before open heart surgery For this patients,after initiation of cardiopulmonary bypass,equal volume of normal salin solution added to cardioplegic solution and The obtained  solution was used without any extra material on the heart tissue during surgery.and they are monitored for five days in the intensive care unit.</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>Dr Rozita Jalalian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Artesh BLVD- Mazandaran Heart Center</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818813771</zip>
        <telephone>+98 11 3332 4002</telephone>
        <email>rozitajalalian@yahoo.com; mahsa_maleki4478@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Rozita Jalalian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Artesh BLVD- Mazandaran Heart Center</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818813771</zip>
        <telephone>+98 11 3332 4002</telephone>
        <email>rjalalian@mazums.ac.ir; rozitajalalian@yahoo.com</email>
        <affiliation>Mazandaran University of Medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: All patients who were underwent CABG surgery in Fatemeh Zahra Hospital.&#13;
Exclusion criteria: Contraindication for Beta Blocker; COPD; Advanced AV block; Previous AF rhythm;  HR&lt;60; SBP&lt;90 mmHg; CABG + MVR/AVR; CABG + MV repair</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>81 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I48</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atrial fibrillation and flutter</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Case group:All of patients who are candidated for open heart surgery and didn't have contraindication for Beta blocker underwent premedication with oral carvedilol with doses 6.25 mg twice days for 3 days before open heart surgery, In these patients, at the time of initiation of cardiopulmonary bypass and when using a cardiopulmonary solution for cardiac arrest, n-acetylcysteine at a rate of 4 milimole per liter (50 mg / kg) was added to the second cardioplegic solution in a single dose, and Eventually, the solution is used during the operation on the heart tissue.and they are monitored for five days in the intensive care unit.</i_keyword>
      <i_keyword>Control group:All of patients who are candidated for open heart surgery and didn't have contraindication for Beta blocker underwent premedication with oral carvedilol with doses 6.25 mg twice days for 3 days before open heart surgery For this patients,after initiation of cardiopulmonary bypass,equal volume of normal salin solution added to cardioplegic solution and The obtained  solution was used without any extra material on the heart tissue during surgery.and they are monitored for five days in the intensive care unit.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Atrial Fibrillation. Timepoint: Since the beginning until the completion of data collection. Method of measurement: VAS Monitor.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of intubation. Timepoint: post CABG. Method of measurement: time recording in file.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-09</approval_date>
        <contact_name>Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Three Joibar Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
