<?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>IRCT20170912036157N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-30</date_registration>
      <primary_sponsor>Dean of Research, Rajaie Cardiovascular Medical and Research Center</primary_sponsor>
      <public_title>Effects of dexmedetomidine drug in heart surgery</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effects of dexmedetomidine on clinical outcomes and renal function after heart surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38626</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, researchers use the Stratified Block randomization method and randomize blocks of 3 to 4 people, and the Random Number Generator as the randomization tool. The method of making random sequences is also stratified according to the inotropic drug intake. To conceal the study from the patient and the main physician of the study (double-blind), the allocation of subjects and drugs in the two groups is done by a trained anesthetic technician that records all the cases initially and the final evaluator of the patient has no information on the type of the prescribed drug. Finally, the statistical information of the two groups is given to the analyst, which is not blind to the groups, Blinding description: Patients are unaware of the groups they were allocated into. They receive the medication during anesthesia. Assessment of the target outcomes are performed with the trained nursing staff who are unaware of the groups. Outcome assessors who fill the questionnaires are not informed regarding the patient allocation.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Coronary artery bypass grafting. Condition 2: Aneurysms of the cardiac arteries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: High-dose Pfizer company dexmedetomidine  (0.75 ug/kg/hr) once from anesthesia induction till the end of operation. Intervention 2: Control group: Low dose Pfizer company dexmedetomidine  (0.5 ug/kg/hr) once from anesthesia induction till the end of operation.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ziae Totonchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr cross., Hashemi Rafsanjani Exp.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416771818</zip>
        <telephone>+98 21 2392 4714</telephone>
        <email>ziya189@yahoo.com</email>
        <affiliation>Rajaie Cardiovascular Medical and Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ziae Totonchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Cross., Hashemi Rafsanjani Exp.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416771818</zip>
        <telephone>+98 21 2392 4714</telephone>
        <email>ziya189@yahoo.com</email>
        <affiliation>Rajaie Cardiovascular Medical and Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent for participation
Elective open heart surgery on cardiopulmonary bypass
Age over 18 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Background of preexisting inflammatory disease
history of preexisting renal insufficiency or severe renal disease before operation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.4</hc_code>
      <hc_code>I71</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronary artery aneurysm and dissection</hc_keyword>
      <hc_keyword>Aortic aneurysm and dissection</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>Intervention group: High-dose Pfizer company dexmedetomidine  (0.75 ug/kg/hr) once from anesthesia induction till the end of operation</i_keyword>
      <i_keyword>Control group: Low dose Pfizer company dexmedetomidine  (0.5 ug/kg/hr) once from anesthesia induction till the end of operation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before operation and 6, 12, 24 and 48 hours after operation. Method of measurement: Vital sign monitoring system.</prim_outcome>
      <prim_outcome>Urine output. Timepoint: During cardiopulmonary bypass and 24 and 48 hours after transfer to intensive care unit. Method of measurement: Urine volume measurement.</prim_outcome>
      <prim_outcome>Blood urea nitrogen (BUN). Timepoint: Before operation and 24, 48 and 72 hours after operation. Method of measurement: Auto-analyzer.</prim_outcome>
      <prim_outcome>Mechanical ventilation time. Timepoint: During operation and intensive care unit stay. Method of measurement: Recording the time.</prim_outcome>
      <prim_outcome>Blood and blood products transfusion. Timepoint: In operation room and 48 hours after operation. Method of measurement: Recording the amount received.</prim_outcome>
      <prim_outcome>Inotrope medicines. Timepoint: In the operation room and until 48 hours post-operation. Method of measurement: Recording the administered amount.</prim_outcome>
      <prim_outcome>Diuretics. Timepoint: In the operation room and intensive care unit. Method of measurement: Recording the administered amounts.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before operation and 6, 12, 24 and 48 hours after operation. Method of measurement: Vital sign monitoring system.</prim_outcome>
      <prim_outcome>Mean arterial blood pressure. Timepoint: Before operation and 6, 12, 24 and 48 hours after operation. Method of measurement: Vital sign monitoring system.</prim_outcome>
      <prim_outcome>Creatinine. Timepoint: Before operation and 24, 48 and 72 hours after operation. Method of measurement: Auto-analyzer.</prim_outcome>
      <prim_outcome>Intensive care unit (ICU) stay. Timepoint: During Intensive care unit (ICU) stay. Method of measurement: Recording the time.</prim_outcome>
      <prim_outcome>Operation time. Timepoint: During operation. Method of measurement: Recording the time.</prim_outcome>
      <prim_outcome>Cardiopulmonary bypass (CPB) duration. Timepoint: During CPB. Method of measurement: Recording the time.</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>Dean of Research, Rajaie Cardiovascular Medical and Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-23</approval_date>
        <contact_name>Ethics Comittee, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Scien</contact_name>
        <contact_address>Valiasr Cross., Hashemi-Rafsanjani Exp. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
