<?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>IRCT201410285140N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-19</date_registration>
      <primary_sponsor>Vice chancellor of research-Faculty of Medicine-Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Fluid therapy in Thyroidectomy Surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of fluid therapy based on plethysmographic Variability Index (PVI) and conventional method on postoperative lactate levels in patients undergoing thyroidectomy surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5480</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Fluid Therapy.</hc_freetext>
      <i_freetext>Intervention 1: In group A:  During surgery once PVI &gt; 13 %, a 250 mL crystalloid is  infused and repeated for every 5 minutes up to three times. Intervention 2: In group B: 4-8 mL/kg/h crystalloid fluid infusion is maintained, and quick fluid infusion is initiated if mean arterial blood pressure (MAP) &lt; 65 mmHg.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Ali Movafegh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Shariati Hospital, North Kargar Ave, Amir Abad, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8490 2282</telephone>
        <email>movafegh@sina.tums.ac.ir</email>
        <affiliation>Professor of Anesthesiology, Dr shariati Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali Movafegh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Shariati Hospital, North Kargar Ave, Amir Abad, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8490 2282</telephone>
        <email>movafegh@sina.tums.ac.ir</email>
        <affiliation>Department of Anesthesiology, Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients aged 18 to 60 years; American Society of anesthesiologists physical status class I and II; A body mass index (BMI) less than 30 kilograms per cubic meter. &#13;
Exclusion criteria: History of systemic (cardiovascular, renal, hepatic, or vascular) disorders; Inadequate peripheral intravenous access; Prolonged surgery (longer than 3 hours);intraoperative dysrhythmias;</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R83-R89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abnormal findings on examination of other body fluids, substances and tissues, without diagnosis</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>In group A:  During surgery once PVI &gt; 13 %, a 250 mL crystalloid is  infused and repeated for every 5 minutes up to three times.</i_keyword>
      <i_keyword>In group B: 4-8 mL/kg/h crystalloid fluid infusion is maintained, and quick fluid infusion is initiated if mean arterial blood pressure (MAP) &lt; 65 mmHg.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amounts of lactate in fluid therapy according to PVI (plethysmographic variation Index). Timepoint: On admission as well as at the end of surgery. Method of measurement: Millimole/liter , Enzymatic.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total amount of intraoperative fluids infused after fluid therapy according to conventional method. Timepoint: End of surgery. Method of measurement: Milliliter.</sec_outcome>
      <sec_outcome>Amounts of lactate in fluid therapy according to conventional method. Timepoint: on admission as well as at the end of surgery. Method of measurement: Millimole/liter, Enzymatic.</sec_outcome>
      <sec_outcome>Mean arterial pressure during fluid therapy according to conventional method. Timepoint: Before anesthesia as well as 1, 2, 3, and 5 minutes after that. Method of measurement: Using patients monitoring - millimeter of mercury.</sec_outcome>
      <sec_outcome>Total amounts of Urine output after fluid therapy according to conventional method. Timepoint: End of surgery. Method of measurement: Milliliter.</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>Vice chancellor of research-Faculty of Medicine-Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-29</approval_date>
        <contact_name>Ethic Committee, Faculty of Medicine of Tehran University of Medical Sciences</contact_name>
        <contact_address>Research Deputy, Ethics Committee of Tehran University of Medical Sciences, 6th floor, Tehran University of Medical Sciences building, Ghods St, Keshavarz Blvd  Tehran   Iran, Islamic Republic Of Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
