<?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>IRCT20190719044274N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-28</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Goal directed fluid therapy in spine surgery</public_title>
      <acronym></acronym>
      <scientific_title>Effects of goal-directed fluid therapy using LiDCOrapid system in postoperative outcomes and comparison with standard fluid therapy for patients undergoing spine surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41072</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: Simple randomization
After providing explanations about the goals of the research and obtaining informed consent, 40 patients undergoing Spine surgery will be selected with a simple random sampling method. Then they are divided into the case and control groups by simple randomization method, Blinding description: people who were responsible for making assessments on postoperative outcomes or gathering data on outcome variables were blinded
Also the people who analysed the data collected during this trial were blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with spine surgery due to Spinal canal stenosis, spondylopathies and etc with past medical history of Hypertension or Diabetes mellitus, Ischemic heart disease, Chronic obstructive pulmonary disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Fluid therapy based on Hemodynamic Monitoring such as Stroke Volume Variation, Cardiac Output, Systemic Vascular Resistance and etc given by LidcoRapid Hemodynamic monitoring. Serum type will be crystalloid (lactated ringer). Intervention 2: Control group: In Control group fluid therapy would be based on standard protocols which is 4 cc/kg/h. If bleeding reaches to the maximum allowable blood loss blood transfusion will be started. Serum type will be crystalloid (lactated ringer).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is After completion of the study, if necessary, the encoded data will be published along with the article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Reza shariat Moharari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences, Qods St, Keshavarz blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8889 6696</telephone>
        <email>Moharari@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr reza shariat Moharari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Scinces, Keshavarz Blvd, Qods st, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8889 6696</telephone>
        <email>Moharari@tums.c.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>operations longer than 2 hours
Ischemic heart disease
Chronic obstructive pulmonary disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient refusal
Irregular heart rhythm</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M47</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spondylosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Fluid therapy based on Hemodynamic Monitoring such as Stroke Volume Variation, Cardiac Output, Systemic Vascular Resistance and etc given by LidcoRapid Hemodynamic monitoring. Serum type will be crystalloid (lactated ringer)</i_keyword>
      <i_keyword>Control group: In Control group fluid therapy would be based on standard protocols which is 4 cc/kg/h. If bleeding reaches to the maximum allowable blood loss blood transfusion will be started. Serum type will be crystalloid (lactated ringer).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Base excess. Timepoint: Before intervention and 1, 2, 3 hours after intervention. Method of measurement: Arterial blood gas.</prim_outcome>
      <prim_outcome>Days of hospital stay. Timepoint: ِDays of hospital stay after surgery. Method of measurement: Reading the files and visiting patients.</prim_outcome>
      <prim_outcome>Days of Intensive Care Unit stay. Timepoint: Days of Intensive Care Unit stay after surgery. Method of measurement: Reading the files and visiting patients.</prim_outcome>
      <prim_outcome>Postoperative nausea and vomiting. Timepoint: Nausea and vomiting after 12, 24 and 36 hours after surgery. Method of measurement: History Taking.</prim_outcome>
      <prim_outcome>Pulmonary edema. Timepoint: Until 24 hours after surgery. Method of measurement: Chest Radiography and Physical examination.</prim_outcome>
      <prim_outcome>Serum Transfusion. Timepoint: During Surgery. Method of measurement: Measurement of Serum given during surgey.</prim_outcome>
      <prim_outcome>Oral intake Tolerance. Timepoint: 24 hours after surgery. Method of measurement: History taking.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Acute Respiratory Distress Syndrome. Timepoint: 48 hours after surgery. Method of measurement: Chest Radiography, Blood gas analysis.</sec_outcome>
      <sec_outcome>Pneumonia. Timepoint: 48 hours after surgery. Method of measurement: Clinical manifestation and Chest radiography.</sec_outcome>
      <sec_outcome>Myocardial infarction. Timepoint: 48 hours after surgery. Method of measurement: Lab tests and Electrocardiography.</sec_outcome>
      <sec_outcome>Hospital readmission. Timepoint: 30 days after discharge. Method of measurement: Postoperative evaluation.</sec_outcome>
      <sec_outcome>Urinary Tract Infection. Timepoint: 48 hours after surgery. Method of measurement: Clinical manifestation, Urine analysis.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-30</approval_date>
        <contact_name>Ethics committee of the Tehran University of medical sciences</contact_name>
        <contact_address>Keshavarz Blvd, Qods St, Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
