<?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>IRCT20140310016917N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-11</date_registration>
      <primary_sponsor>Vice chancellor for research of Guilan University of Medical Sciences</primary_sponsor>
      <public_title>Inhaled heparin in pneumonia</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effect of inhaled heparin on  duration of antibiotic therapy in patients with ventilator associated pneumonia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40133</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Out of 42 subjects who entered the study by random block method, Individuals are randomly assigned to both interventional and non-interventional groups (with placebo)by statistical random generator software, Blinding description: Once the subjects in the study groups have been identified, the drug and placebo are placed in the same syringes as they are in appearance, and thus patients will not be informed of the contents inside it.</study_design>
      <phase>2-3</phase>
      <hc_freetext>VENTILATOR ASSOCIATED PNEUMONIA(VAP).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  after appropriate  randomization drug (nebulized heparin in this group) in dose of 2 cc (10,000 heparin units) every 4 hours is given through a jet nebulizer  located 30 cm in the tracheal tube at the inspiratory  arm of ventilator.Other measures will be exactly the same as the recipients of standard pneumonia treatment (control group).The Heparin ampoule is supplied by the Caspian Company and is at 5000 units per cc. Intervention 2: Control group: after appropriate  randomization drug (distilled water in this group) in dose of 2 cc  every 4 hours is given through a jet nebulizer  located 30 cm in the tracheal tube at the inspiratory  arm of ventilator and standard treatment consistent of  antibiotics in  appropriate for the local prevalency in the ICU initially  was started and then continued  on the basis of culture of pulmonary secretions until the pro calcitonin serum level is in the non  infected stage or at most 14 days.</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 To protect the secrets of patients and to observe ethics of study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mostafa Saeedinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poursina hospital</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4139638459</zip>
        <telephone>+98 13 1321 0434</telephone>
        <email>mostafa.saeedinia@gmail.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Ashraf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namjoo Street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713194</zip>
        <telephone>+98 13 1321 0434</telephone>
        <email>aliashraf@gums.ac.ir</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients are included in the study according to the score of the severity of pulmonary infection index (&gt;=6) and age above 18 years old.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Mechanical ventilation less than 48 h during hospitalization
Cancer and immunedeficient patients
chronic infection and coinfection in other sites of body
Do not resuscisate patients
CRRT dependency
Theraputic dose of any anticoagulants
BMI&gt;40
History of allergy to heparin and HIT
History of bleeding in 3 month ago and bleeding tendency
ICH in 1year ago
possibility of epidural catheter insertion during next  48 h</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J95.851</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ventilator associated pneumonia</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 group:  after appropriate  randomization drug (nebulized heparin in this group) in dose of 2 cc (10,000 heparin units) every 4 hours is given through a jet nebulizer  located 30 cm in the tracheal tube at the inspiratory  arm of ventilator.Other measures will be exactly the same as the recipients of standard pneumonia treatment (control group).The Heparin ampoule is supplied by the Caspian Company and is at 5000 units per cc.</i_keyword>
      <i_keyword>Control group: after appropriate  randomization drug (distilled water in this group) in dose of 2 cc  every 4 hours is given through a jet nebulizer  located 30 cm in the tracheal tube at the inspiratory  arm of ventilator and standard treatment consistent of  antibiotics in  appropriate for the local prevalency in the ICU initially  was started and then continued  on the basis of culture of pulmonary secretions until the pro calcitonin serum level is in the non  infected stage or at most 14 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of antibiotic therapy. Timepoint: Every other day, procalcitonin is measured to determine the length of antibiotic treatment. Method of measurement: Procalcitonin  Measuring Kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Clinical pulmonary infection severity score. Timepoint: On admission and daily. Method of measurement: Clinical Information Collection Form.</sec_outcome>
      <sec_outcome>C Reactive Protein. Timepoint: On admission then daily. Method of measurement: Clinical Information Collection Form.</sec_outcome>
      <sec_outcome>Sepsis Organ Failure Assessment score. Timepoint: On admission then daily. Method of measurement: Clinical Information Collection Form.</sec_outcome>
      <sec_outcome>Acute Physiologic And Chronic Health Evaluation II score. Timepoint: on addmision then daily. Method of measurement: Clinical Information Collection Form.</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 for research of Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-29</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Namjoo street Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
