<?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>IRCT20190121042444N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-13</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the Effect of Dexmedetomidine Infusion on Gene Expression of Inflammatory Cytokines &amp; Lymphocyte T CD4 + Transcription Factors in Elective Abdominal Aortic Aneurysm Repair</public_title>
      <acronym>-</acronym>
      <scientific_title>Evaluating the Effect of Dexmedetomidine Infusion on Gene Expression of Inflammatory Cytokines &amp; Lymphocyte T CD4 + Transcription Factors in Elective Abdominal Aortic Aneurysm Repair</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36997</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: Based on random numbers, the patient and the individual who fill the table are unaware, Blinding description: The patient and anesthetist who fill the table are unaware of the study.</study_design>
      <phase>3</phase>
      <hc_freetext>Abdominal Aortic Aneurysm.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group was subjected to anxiolytic infusion with doses of 0.3 mg / kg / hour doses of DEX until aortic clamp. Patients' blood samples were taken to determine the level of inflammatory cytokines and the level of expression of inflammatory mRNAs in the preoperative period, after induction of anesthesia, 24 hours after surgery, 4 days after surgery, and at discharge time, from a patient's peripheral blood sample size And the effect of DEX on them will be investigated. Intervention 2: Control group:  There are no interventions in this group.</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:
A portion of the information, such as information on the main outcome or the like, can be shared

When:
1399

To whom:
Researchers working in academia and academia

Conditions:
Analyzes on the delivered data are allowed

Where to obtain:
Shohada Tajrish Hospital Department of Anesthesiology - Maidan Tajrish Building No. 1 Second Floor Operation Room Dr. Behnaz Telephone 22741174
Shohada Tajrish Hospital - Tajrish Square Building No. 1 Second Floor Ms. َ Arinnia Telephone 22718002 Internal 310

How to obtain:
Apply for one month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>faranak behnaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>tajrish Sq;shohada hospital</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21 2274 1174</telephone>
        <email>faranak.behnaz@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>faranak behnaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>tajrish Sq;shohada hospital</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21 2274 1174</telephone>
        <email>faranak.behnaz@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with abdominal aortic aneurysms referring to Shohadaye Tajrish Hospital who are candidates for elective aneurysm repair surgery will be included in the study.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous history of aortic surgery
ASA Class III and above
IBD
Malignancies
Chronic inflammatory diseases
Taking corticosteroids
Emergency surgery
Any unstable patient during surgery
Any addiction</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>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group was subjected to anxiolytic infusion with doses of 0.3 mg / kg / hour doses of DEX until aortic clamp. Patients' blood samples were taken to determine the level of inflammatory cytokines and the level of expression of inflammatory mRNAs in the preoperative period, after induction of anesthesia, 24 hours after surgery, 4 days after surgery, and at discharge time, from a patient's peripheral blood sample size And the effect of DEX on them will be investigated.</i_keyword>
      <i_keyword>Control group:  There are no interventions in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Relative level of mRNA; IL6. Timepoint: Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharge. Method of measurement: Sampling from patient's blood and filling in the questionnaire.</prim_outcome>
      <prim_outcome>Relative level of mRNA; TNF-α. Timepoint: Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharge. Method of measurement: Sampling from patient's blood and filling in the questionnaire.</prim_outcome>
      <prim_outcome>Relative level of Foxp3 mRNA. Timepoint: Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharge. Method of measurement: Sampling from patient's blood and filling in the questionnaire.</prim_outcome>
      <prim_outcome>Relative level of GATA3mRNA. Timepoint: Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharge. Method of measurement: Sampling from patient's blood and filling in the questionnaire.</prim_outcome>
      <prim_outcome>Relative level of IL-1mRNA. Timepoint: Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharge. Method of measurement: Sampling from patient's blood and filling in the questionnaire.</prim_outcome>
      <prim_outcome>Relative level of ROR-. Timepoint: Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharge. Method of measurement: Sampling from patient's blood and filling in the questionnaire.</prim_outcome>
      <prim_outcome>Relative level of T-bet mRNA. Timepoint: Before the beginning of the intervention (beginning of the study), the first day and the third day, and the time of discharg. Method of measurement: Sampling from patient's blood and filling in the questionnaire.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-04</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Vel'yanjak Ave Shahid Beheshti University Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
