<?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>IRCT20190413043252N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-18</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The effect of sulfate magnesium on atrial fibrillation after open heart surgery</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of sulfate magnesium tablet on atrial fibrillation after coronary artery bypass grafting in Heshmat Hospital in 2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38795</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be selected based on inclusion criteria and then classified into two groups receiving magnesium sulfate and control group, using the random block method in quadruple blocks based on the obtained list. To generate random sequences in this clinical trial, http://www.graphpad.com/quickcalcs/index.cfm will be used.</study_design>
      <phase>3</phase>
      <hc_freetext>Atrial fibrillation and fluttery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: All pre-operative patients will be interviewed and the method will be explained to them and written informed consent will be obtained. In both groups, a blood sample for magnesium serum will be taken first and if it is within the normal range (1/5-2/5 milliequivalents per liter), from 48 hours pre-operation, a 250 milligrams magnesium tablet (manufacturer: 21st century)will be given to intervention group at 6 am. This step is done by a collaborator nurse. After surgery and transfer to the ICU, both groups of patients undergo intensive care and ECG monitoring. The intervention group, in case of staying intubated they will take the tablet through NGT tube and if extubated they will take it orally their next 6 am tablet and it will be continued till the fifth day after surgery. The nurse giving the drug to the patient is not in the care team. Magnesium level of plasma in both groups will be controlled daily and if it was higher than the normal range, the medication will be stopped. All this time, a collaborator anesthetist is aware of receiving the drug by intervention group and will intervene immediately in the event of a complication. Intervention 2: Control group: This group does not receive any drug.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is not decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholamreza Kanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Heshmat Hospital,at the beginning of bayani street,Mosalla Square</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4144654839</zip>
        <telephone>+98 13 3366 9066</telephone>
        <email>dr_kanani@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamreza Kanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Heshmat Hospital,at the beginning of bayani street,Mosalla Square</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4144654839</zip>
        <telephone>+98 13 3366 9066</telephone>
        <email>dr_kanani@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Only cardiopulmonary bypass graft surgery (not associated with valve operation).
First-time open heart surgery
Ejection Fraction(EF) more than 35%</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of Previous arterial fibrillation(AF)
History of kidney disease
History of taking magnesium and showing an allergic reaction
History of taking antiarrhythmic drugs (such as amiodarone -digoxin -warfarin)
Being pregnant
Having a pacemaker
AV BLOCK In the ECG</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>شماره 148</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>IX 100-199 Diseases of the circulatory system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: All pre-operative patients will be interviewed and the method will be explained to them and written informed consent will be obtained. In both groups, a blood sample for magnesium serum will be taken first and if it is within the normal range (1/5-2/5 milliequivalents per liter), from 48 hours pre-operation, a 250 milligrams magnesium tablet (manufacturer: 21st century)will be given to intervention group at 6 am. This step is done by a collaborator nurse. After surgery and transfer to the ICU, both groups of patients undergo intensive care and ECG monitoring. The intervention group, in case of staying intubated they will take the tablet through NGT tube and if extubated they will take it orally their next 6 am tablet and it will be continued till the fifth day after surgery. The nurse giving the drug to the patient is not in the care team. Magnesium level of plasma in both groups will be controlled daily and if it was higher than the normal range, the medication will be stopped. All this time, a collaborator anesthetist is aware of receiving the drug by intervention group and will intervene immediately in the event of a complication.</i_keyword>
      <i_keyword>Control group: This group does not receive any drug.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Effect on prevention of AF rhythm in patients with coronary artery bypass graft surgery. Timepoint: 24-hour patient monitoring until the fifth day. Method of measurement: ECG monitoring.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reducing hospitalization time in the ICU and hospital, and thus reducing patient hospitalization costs. Timepoint: After patient's discharge from  hospital. Method of measurement: Number of hospitalization days.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-09</approval_date>
        <contact_name>Ethics Committee Of Guilan University Of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
