<?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>IRCT20190218042749N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-15</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Pulsatile and Non-pulsatile Perfusion Flow on Renal Function during Coronary Artery Bypass Grafting Surgery in Patients with Left Ventricular Dysfunction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Pulsatile and Non-pulsatile Perfusion Flow on Renal Function during Coronary Artery Bypass Grafting Surgery in Patients with Left Ventricular Dysfunction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37779</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients participating in the study were divided into two intervention and control groups by throwing coins, Blinding description: In this study: participants, the researcher, medical staff(physicians and nurses), those responsible for data collection, the individuals who analyzed the final results, and those who prepared the paper draft.</study_design>
      <phase>3</phase>
      <hc_freetext>Patients  who have Coronary Artery Disease  candidate of  CABG with left  ventricular  dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Control group: CABG candid patients  who suffer from left ventricular dysfunction and received non-pulsatile flow during the surgery via Pump machine. Intervention 2: Intervention group: CABG candid patients  who suffers from left ventricular dysfunction and received pulsatile flow during the surgery via Pump machine.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Patients identity information such as first name, last name, file No. and Hospitalization code are not recorded.

When:
from March-2019

To whom:
Professors, University students and all researches who study the same issue.

Conditions:
In order to get information about different aspects of specialized and applied purposes, hypothesis, research methods, and results in order to be used with citations as a reference in future studies.

Where to obtain:
Library of Shiraz University of Medical Sciences and Anaesthesia Department Library located at Shiraz University of Medical Sciences

How to obtain:
The applicant can find access to data after presenting his/her personal ID card with this explanation that he/she is not allowed to take photos of the document or to take it out of the library.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Zamani Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Motahari St.,Pardis Site, After Nursing College, Jahrom, Iran</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۶۱۹۹- ۷۴۱۴۸</zip>
        <telephone>+98 71 5426 7727</telephone>
        <email>marziehzamani@jums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Zamani Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Motahari St.,Pardis Site, After Nursing College, Jahrom, Iran</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۶۱۹۹- ۷۴۱۴۸</zip>
        <telephone>+98 71 5426 7727</telephone>
        <email>marziehzamani@jums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients referring to Operation room  for Elective CABG in dependent hospitals to Shiraz University of Medical Sciences
participation satisfaction in attending the project
left Ventricular dysfunction
Bypass Coronary Grafting Surgery
enjoying EF pulsatile  lower than 40 percent( based on Suggestions from American Cardiography  Association) equivalent to severe left  ventricular dysfunction
Ages from 40 to 75</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>lack of patient's tendency to continue the study
simultaneous surgery of Valve and Coronary
Anesthesia risk more than 3
Sepsis
Renal dysfunction (Cr&gt;1.5)
Redo
Liver Dysfunction
Records of brain stroke
Concurrent autoimmune diseases
Records of immunosuppressive drugs, Chemotherapy or radiotherapy
emergency patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.708</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerosis of coronary artery bypass graft(s), unspecified, with other forms of angina pectoris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: CABG candid patients  who suffer from left ventricular dysfunction and received non-pulsatile flow during the surgery via Pump machine</i_keyword>
      <i_keyword>Intervention group: CABG candid patients  who suffers from left ventricular dysfunction and received pulsatile flow during the surgery via Pump machine</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Renal parameter UO24h. Timepoint: Before bypass surgery, During bypass surgery, three days after bypass surgery,. Method of measurement: Laboratory variables were sent to the laboratory and got analyzed with the related devices. 24-hour urine volume after the surgery was measured by the ICU nurses.</prim_outcome>
      <prim_outcome>Renal parameter BUN. Timepoint: Before bypass surgery, During bypass surgery, three days after bypass surgery,. Method of measurement: Laboratory variables were sent to the laboratory and got analyzed with the related devices. 24-hour urine volume after the surgery was measured by the ICU nurses.</prim_outcome>
      <prim_outcome>Renal parameter GFR. Timepoint: Before bypass surgery, During bypass surgery, three days after bypass surgery,. Method of measurement: Laboratory variables were sent to the laboratory and got analyzed with the related devices. 24-hour urine volume after the surgery was measured by the ICU nurses.</prim_outcome>
      <prim_outcome>Renal parameter Cr. Timepoint: Before bypass surgery, During bypass surgery, three days after bypass surgery,. Method of measurement: Laboratory variables were sent to the laboratory and got analyzed with the related devices. 24-hour urine volume after the surgery was measured by the ICU nurses.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>BMI. Timepoint: Before bypass surgery. Method of measurement: Based on Patient's File.</sec_outcome>
      <sec_outcome>Bleeding rate. Timepoint: three days after bypass surgery in ICU. Method of measurement: Bleeding rate was determined based on the scaled chest bottle tube.</sec_outcome>
      <sec_outcome>Gender. Timepoint: Before bypass surgery. Method of measurement: Based on Patient's File.</sec_outcome>
      <sec_outcome>Age. Timepoint: Before bypass surgery. Method of measurement: Based on Patient's File.</sec_outcome>
      <sec_outcome>EF. Timepoint: Before bypass surgery. Method of measurement: Based on Patient's 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-23</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Central Building of Medical Sciences University, Across from Felestin St., Zand St., Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
