<?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>IRCT20200825048509N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-19</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Renal function in pulsatile and non-pulsatile perfusion in patient undergoing coronary artery surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Review and compare of renal function in pulsatile and non-pulsatile perfusion in patient undergoing coronary artery surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50514</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Surgeon and the nurse involved in the study were not aware of the kind of perfusion applied to the patient, Blinding description: Surgeon and the nurses involved in the study were not aware of the kind of perfusion applied to the patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group of patients undergoing coronary artery surgery with pulsatile blood flow of pump                                                                  At the open heart surgery room, after anesthesia and opening the patients chest, patients were connected to the heart-lung mashine and in this study the heart-lung mashine was run in pulsatile blood flow mode in the intervention group, urine and blood samples were collected to measure the related variables to renal function such as: blood sodium and potassium before  during and after surgery, Creatinine and BUN before surgery 24 hours after surgery and at releasing time from hospital, urine output before surgery 24 hours after surgery and at releasing time from hospital, and GFR before surgery and at releasing time from hospital. Intervention 2: Control group: Group of patients undergoing coronary artery surgery with non-pulsatile blood flow of pump                                                                                           In this group after connecting to the heart-lung mashine the blood flow was administered non-pulsating and all of the variables related to renal function  such as: blood sodium and potassium before  during and after surgery, Creatinine and BUN before surgery 24 hours after surgery and at releasing time from hospital, urine output before surgery 24 hours after surgery and at releasing time from hospital, and GFR before surgery and at releasing time from hospital were collected and measured.                                                                        In order to compare the variable between two groups spss software was used to see if the differences are statistically significant or not.</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 no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahra Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bostan Ave, South Valieasr Blv, Baharestan, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8143176944</zip>
        <telephone>+98 31 3650 2537</telephone>
        <email>Sahrasalehi90@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sahra Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bostan Ave, South Valieasr Blv, Baharestan, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8143176944</zip>
        <telephone>+98 31 3650 2537</telephone>
        <email>Sahrasalehi90@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age above 18 years
Coronary artery surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering MI in the last two weeks
Off pump surgery
Urgent surgery
untreated diabetes
Abnormal liver function
Reduced level of consciousness before surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic ischemic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group of patients undergoing coronary artery surgery with pulsatile blood flow of pump                                                                  At the open heart surgery room, after anesthesia and opening the patients chest, patients were connected to the heart-lung mashine and in this study the heart-lung mashine was run in pulsatile blood flow mode in the intervention group, urine and blood samples were collected to measure the related variables to renal function such as: blood sodium and potassium before  during and after surgery, Creatinine and BUN before surgery 24 hours after surgery and at releasing time from hospital, urine output before surgery 24 hours after surgery and at releasing time from hospital, and GFR before surgery and at releasing time from hospital.</i_keyword>
      <i_keyword>Control group: Group of patients undergoing coronary artery surgery with non-pulsatile blood flow of pump                                                                                           In this group after connecting to the heart-lung mashine the blood flow was administered non-pulsating and all of the variables related to renal function  such as: blood sodium and potassium before  during and after surgery, Creatinine and BUN before surgery 24 hours after surgery and at releasing time from hospital, urine output before surgery 24 hours after surgery and at releasing time from hospital, and GFR before surgery and at releasing time from hospital were collected and measured.                                                                        In order to compare the variable between two groups spss software was used to see if the differences are statistically significant or not.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in renal function. Timepoint: Before surgery, during surgery, 24 hours after surgery, at the releasing time from hospital. Method of measurement: Getting blood and urine sample.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Yazd University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Yazd University of Medical Sciences</source_name>
      <source_name>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-06</approval_date>
        <contact_name>Ethics committee of Yazd Shahid Sadoughi University of medical sciences</contact_name>
        <contact_address>Bostan Ave, South Valieasr Blv, Baharestan, Isfahan. Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
