<?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>IRCT20190922044844N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-03</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of effect of two different frequencies of Intra-aortic balloon pump on hemodynamic situation in patients after Coronary Artery Bypass Graft</public_title>
      <acronym>IABP</acronym>
      <scientific_title>Comparison of effect of 1:1 and 1:2 frequency of Intra-aortic balloon pump on hemodynamic situation in patients with medium dose of inotrope after Coronary Artery Bypass Graft</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>9</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42382</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Influence of 1: 1 and 1: 2 frequency balloon pumps.</hc_freetext>
      <i_freetext>This design is a quasi-experimental study of pre-test - posttest that compares all those who were at the 1: 1 frequency before and at the start of the intervention with the 1: 2 frequency step..</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 Due to secondary data analysis</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir mirmohammadsadeghy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of the Tower Garden 1, Corner of the Tower, Nizwan, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1611812345</zip>
        <telephone>+98 31 3773 3390</telephone>
        <email>am_sadeghi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir mirmohammadsadeghy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of the Tower Garden 1, Corner of the Tower, Nizwan, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1611812345</zip>
        <telephone>+98 31 3773 3390</telephone>
        <email>am_sadeghi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People who underwent CABG but due to low cardiac output, mean arterial blood pressure less than 80 mmHg failed to separate from the cardiopulmonary pump device and required postoperative IABP.
Patients who are consenting to participate in the project, which will be obtained from the legal guardian if the patient is unconscious.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who perform CABG at the same time as aortic valve and arch operations such as: aortic valve replacement, Bental surgery, etc.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This design is a quasi-experimental study of pre-test - posttest that compares all those who were at the 1: 1 frequency before and at the start of the intervention with the 1: 2 frequency step.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of change in the velocity time integral of aortic blood flow during systole. Timepoint: In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again. Method of measurement: The velocity time integral value of aortic blood flow during systole is measured by echocardiography.</prim_outcome>
      <prim_outcome>The measurement of area left ventricular outflow tract ( area LVOT). Timepoint: At moderate doses of inotropic drugs, this variable is measured before the intervention begins. Method of measurement: This variable is measured by echocardiography,.</prim_outcome>
      <prim_outcome>Rate of change in systolic blood pressure in patients. Timepoint: In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again. Method of measurement: it's measured by a built-in arterial line for patients and cardiac monitoring devise.</prim_outcome>
      <prim_outcome>Rate of change in diastolic blood pressure in patients. Timepoint: In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again. Method of measurement: it's measured by a built-in arterial line for patients and cardiac monitoring devise.</prim_outcome>
      <prim_outcome>Rate of change in heart rates in patients. Timepoint: In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again. Method of measurement: it's measured by a cardiac monitoring devise.</prim_outcome>
      <prim_outcome>Rate of change in mean arterial blood pressure in patients. Timepoint: In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again. Method of measurement: it's measured by a built-in arterial line for patients and cardiac monitoring devise.</prim_outcome>
      <prim_outcome>The measure of body surface area. Timepoint: At moderate doses of inotropic drugs, this variable is measured before the intervention begins. Method of measurement: This variable is measured by echocardiography,.</prim_outcome>
      <prim_outcome>Rate of change in cardiac output of patients. Timepoint: In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again. Method of measurement: It will be calculated by the formula and collected required data.</prim_outcome>
      <prim_outcome>Rate of change in cardiac index of patients. Timepoint: In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again. Method of measurement: It will be calculated by the formula(cardiac output divided by body surface area) and collected required data.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-28</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Unit 24, No. 73, Hoquqi Ave., Somayeh Cross., Shariaty Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
