<?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>IRCT2015101924606N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-13</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>End tidal carbon dioxide pressure in patients with septic shock</public_title>
      <acronym></acronym>
      <scientific_title>Comparison Dopamine and Nor-epinephrine on End tidal carbon dioxide pressure in patients with septic shock</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-02-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>138</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20733</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization
Patients were divided into two groups and randomly assigned to each of the two groups. The drugs in each group were of the same size and shape, each of these numbers was coded and sealed in a seal envelope, Blinding description: Drugs in a similar container in an opaque bag numbered and the prescribing physician and nurse practitioner were unaware.</study_design>
      <phase>3</phase>
      <hc_freetext>Septic Shock.</hc_freetext>
      <i_freetext>Intervention 1: Amp Neurepinephrine, 0.5 micro gram/kilogram/minutes, For 2 hours. Intervention 2: Amp Dopamine, 5microgram/kilogram/minutes, For 2 hours.</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:
All potential data is shared after unidentifiable people

When:
It has started in 2016

To whom:
Academic researchers

Conditions:
All data analysis and actions are coordinated and informed by the project manager

Where to obtain:
Project Officer - Research Deputy of Mazandaran University of Medical Sciences

How to obtain:
Written Request to Research Deputy of Mazandaran University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamed Aminiahidashti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Department, Imam Khomeini Hospital, Amirmazandarani avenue</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816633131</zip>
        <telephone>+98 11 3336 1700</telephone>
        <email>h.aminiahidashti@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed Aminiahidashti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Department, Imam Khomeini Hospital, Amirmazandarani avenue</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816633131</zip>
        <telephone>+98 11 3336 1700</telephone>
        <email>h.aminiahidashti@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with septic shock conditions</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients under 18 years
patients more than 75 year
Those who received more than 4 hours vasopressor drugs brain death
Those with severe cardiac arrhythmia
Traumatic patient
Brain death</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Septicaemia, unspecified, Septic Shock</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>Amp Neurepinephrine, 0.5 micro gram/kilogram/minutes, For 2 hours</i_keyword>
      <i_keyword>Amp Dopamine, 5microgram/kilogram/minutes, For 2 hours</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: mmhg,  manometer.</prim_outcome>
      <prim_outcome>End Tidal Carbon Dioxide Pressure. Timepoint: Before intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: mmhg, capnograph.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart Rate. Timepoint: Before intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: number per minutes.</sec_outcome>
      <sec_outcome>Oxygen Saturation. Timepoint: Before intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: Puls oxymeter.</sec_outcome>
      <sec_outcome>Carbon Dioxide Pressure. Timepoint: Before intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: Blood gas.</sec_outcome>
      <sec_outcome>Oxygen Pressure. Timepoint: Before intervention, 30 minutes after intervention, 120 minutes after intervention. Method of measurement: Blood gas.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-17</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی مازندران</contact_name>
        <contact_address>Mazandaran University of Medical Sciences, Jooybar treeway, Imam Square Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
