<?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>IRCT20171106037280N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-28</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>The effects of etomidate and ketamine on outcome of adult patients with multiple trauma requiring tracheal intubation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of etomidate versus ketamine on outcome of adult patients with multiple trauma requiring rapid sequence intubation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32996</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization with allocating random numbers to patients and selecting the drug based on that number, Blinding description: Patients and medications are marked with numbers which are unknown for patients and investigators, at the end of the study it is revealed that which number is representative of which medication for each patient.</study_design>
      <phase>3</phase>
      <hc_freetext>intubation in trauma patient.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:ketamine: ketamine 3 mg/kg IV infusion, administered once at the beginning of the intervention for induction during rapid sequence intubation. Intervention 2: Intervention group2:etomidate: etomidate 0.3 mg/kg IV infusion, administered once at the beginning of the intervention for induction during rapid sequence intubation.</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:
The collected data about outcome will be disclosed

When:
The data will be published 1 year after the results.

To whom:
Students and physicians and lecturers

Conditions:
Data can be used under copyright rules.

Where to obtain:
Data will be in access by sending an e-mail to H-sotude@razi.tums.ac.ir.

How to obtain:
The data would be reachable for whom with a qualified letter from research department of their university or institute.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamed Sotoude</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sanandaj, Pasdaran st., Kowsar hospital, emergency department</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618634683</zip>
        <telephone>+98 87 3366 2027</telephone>
        <email>H-sotude@razi.tums.ac.ir</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed Sotoude</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sanandaj, Pasdaran st., Kowsar hospital, emergency department</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618634683</zip>
        <telephone>+98 87 3366 2027</telephone>
        <email>H-sotude@razi.tums.ac.ir</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All adult multiple trauma patients referring to Sanandaj Kowsar Hospital emergency department requiring rapid sequence tracheal intubation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>allergy to drugs
elevated intracerebral or intraocular pressure
hypertention (Blood Pressure&gt;= 160/110 mm Hg)
severe endocrine disorders
active lung disease
tracheal stenosis
obstructive sleep apnea
airway obstruction
laryngospasm
pregnancy or lactation</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1:ketamine: ketamine 3 mg/kg IV infusion, administered once at the beginning of the intervention for induction during rapid sequence intubation.</i_keyword>
      <i_keyword>Intervention group2:etomidate: etomidate 0.3 mg/kg IV infusion, administered once at the beginning of the intervention for induction during rapid sequence intubation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Death at emergency department or during admission at hospital. Timepoint: During emergency department and hospital admission. Method of measurement: Death declaration at his/her documents.</prim_outcome>
      <prim_outcome>Duration of survival days during hospital admission. Timepoint: During emergency or hospital admission (from admission and intubation until death). Method of measurement: Number of survival days.</prim_outcome>
      <prim_outcome>ICU-free days. Timepoint: During hospital admission from intubation to 28 days after admission (ICU-discharge point until 28 days after admission). Method of measurement: Number of ICU-free days.</prim_outcome>
      <prim_outcome>Ventilator-free days. Timepoint: During hospital admission from intubation to 28 days after admission (the time of weaning from mechanical ventilation until 28 days after admission). Method of measurement: Number of ventilator-free days.</prim_outcome>
      <prim_outcome>Vasopressor free days. Timepoint: During hospital admission from intubation to 28 days after admission (the time of stopping vasopressor infusion until 28 days after admission). Method of measurement: Number of vasopressor-free days.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of transfused packed-RBCs. Timepoint: During the first 48 hours from admission. Method of measurement: Number of transfused packed-RBCs documented on patient file.</sec_outcome>
      <sec_outcome>Sepsis incidence. Timepoint: During the first 28 days from admission. Method of measurement: Having 2 or more criteria form SIRS associated with an infection focus during the first 28 days from admission.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-14</approval_date>
        <contact_name>Ethics committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Pasdaran St., Kurdistan University of Medical Sciences, Research Department Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
