<?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>IRCT20190506043492N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-22</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of the effect of inhaled heparin in the treatment of patients with adult respiratory distress syndrome hospitalized in the intensive care unit</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the effect of inhaled heparin in the treatment of patients with adult respiratory distress syndrome hospitalized in the intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49030</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly selected and divided into two groups of intervention (heparin recipient) and control (normal saline recipient) through a table of random numbers assigned to even numbers for the intervention group and individual numbers for the control group, Blinding description: In this study, the person who injected the drug was unaware that the syringe contained heparin or normal saline because the drug was taken by another anesthesiologist and stamped 1 and 2, and the person who took the blood sample for coagulation tests Patients were unaware of the type of intervention and the type of medication that had been injected for the patients. In this study, statistical analyzer was also unaware of the type of groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute respiratory distress syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group In addition to routine care, 5,000 units are used every 12 hours for 7 days.The heparin used is 5,000 units produced by Iran Pakhsh Broadcasting Company, which is diluted with 2 cc of distilled water and then poured into a nebulizer device and the nebulizer is connected to the chip pipe and the ventilator is connected. Intervention 2: Control group: In addition to routine care, patients in the control group poured 2 cc of normal saline into the nebulizer every 12 hours for 7 days, and the nebulizer was connected to the chip tube and then to the ventilator.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nastaran sadat Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3373 8383</telephone>
        <email>Eglantin92@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nastaran sadat Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3373 8383</telephone>
        <email>Eglantin92@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients 18 to 60 years
Under mechanical ventilation for more than 48 hours
Respiratory index PAO2 / FIO2 ≤200 mmhg
Bilateral pulmonary infiltration in the chest x-ray
Lack of heart disease and previous lung disease
Positive end expiratory pressure or PEEP≥ ventilator 5 cmh2
No history of intracerebral hemorrhage in the past 12 months
No history of heparin-induced thrombocytopenia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction to continue working on the study
Hypersensitivity to heparin
Uncontrolled bleeding or bleeding disorders
PTT and INR impaired
Patients receiving therapeutic doses of heparin, anaxaparin and warfarin</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute respiratory distress syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in the intervention group In addition to routine care, 5,000 units are used every 12 hours for 7 days.The heparin used is 5,000 units produced by Iran Pakhsh Broadcasting Company, which is diluted with 2 cc of distilled water and then poured into a nebulizer device and the nebulizer is connected to the chip pipe and the ventilator is connected.</i_keyword>
      <i_keyword>Control group: In addition to routine care, patients in the control group poured 2 cc of normal saline into the nebulizer every 12 hours for 7 days, and the nebulizer was connected to the chip tube and then to the ventilator.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Respiratory index: PAO2 / FIO2. Timepoint: 1 to 7 days after the intervention. Method of measurement: Ventilator.</prim_outcome>
      <prim_outcome>Arterial blood gas parameters. Timepoint: 1 to 7 days after the intervention. Method of measurement: ABG test.</prim_outcome>
      <prim_outcome>The amount of PEEP required for effective mechanical ventilation. Timepoint: 1 to 7 days after the intervention. Method of measurement: Ventilator.</prim_outcome>
      <prim_outcome>The time required for mechanical ventilation. Timepoint: 1 to 7 days after the intervention. Method of measurement: The number of days it has been subjected to mechanical ventilationnumber.</prim_outcome>
      <prim_outcome>Mortality rate is 48 hours and 7 days. Timepoint: 1 to 7 days after the intervention. Method of measurement: Mortality rate.</prim_outcome>
      <prim_outcome>Respiratory parameters. Timepoint: 1 to 7 days after the intervention. Method of measurement: Lung capacity، Tidal Volume, Respiratory rate, Minute Ventilation, Paco2.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-25</approval_date>
        <contact_name>Ethics committee of ahvaz jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
