<?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>IRCT201203089235N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-10-16</date_registration>
      <primary_sponsor>Tehran university medical scince</primary_sponsor>
      <public_title>Determination of mgso4 infusion effect for treatment of patient with acute pulmonary edema arrived rasol and sina hospital from khordad 1391 to khordad 1392</public_title>
      <acronym></acronym>
      <scientific_title>Determination of mgso4 infusion effect for treatment of patient with acute pulmonary edema arrived rasol and sina hospital from  khordad 1391 to khordad 1392</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9826</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute pulmonary edema.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group start treatment by o2 until o2Sat of patient &gt;94% (minimum by 4 lit/min o2),plus Amp lasix 1 mgr/kg and Amp nitroglycerin  5 mic gr/min started and titrated 5 mic gr/min if patients blood pressure permitted, and Amp morphine sulfate 0.05 mgr/kg for attention of patient blood pressure (preferly systolic blood pressure&gt; 90 mmhg).these treatment are basic treatment of acute pulmonary edema.&#13;
in addition to in intervention group gives 1 gr Mgso4 in 100 cc normal saline for 20 min. Intervention 2: In control group start treatment by o2 until o2Sat of patient &gt;94% (minimum by 4 lit/min o2),Amp lasix 1 mgr/kg and Amp nitroglycerin by 5 mi cgr/min started and titrated 5 mi cgr/min if patients blood pressure permitted, and Amp morphine sulfate 0.05 mgr/kg for attention of patient blood pressure (preferly systolic blood pressure&gt; 90 mm hg).these treatment are basic treatment of acute pulmonary edema.but in control group we administrate basic treatment of acute pulmonary edema and not infused Mgso4. as we administrate 100 cc normal saline in 20 min for placebo instead Mgso4.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Seyyed Mahdi Zia Ziabari M.D</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Satarkhan shahrara rasoul hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6652 5327</telephone>
        <email>smzz592000@yahoo.com</email>
        <affiliation>Tehran university medical scince</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Peyman Hafezi Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Satarkhan shahrara rasoul hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6652 5327</telephone>
        <email>hafezimoghadam@yahoo.com</email>
        <affiliation>Tehran university medical scince</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:patient with acute pulmonary edema&#13;
Exclusion criteria:presence of mgso4 side effects</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>150.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>with mention of heart disease NOS or heart failure</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>In intervention group start treatment by o2 until o2Sat of patient &gt;94% (minimum by 4 lit/min o2),plus Amp lasix 1 mgr/kg and Amp nitroglycerin  5 mic gr/min started and titrated 5 mic gr/min if patients blood pressure permitted, and Amp morphine sulfate 0.05 mgr/kg for attention of patient blood pressure (preferly systolic blood pressure&gt; 90 mmhg).these treatment are basic treatment of acute pulmonary edema.&#13;
in addition to in intervention group gives 1 gr Mgso4 in 100 cc normal saline for 20 min.</i_keyword>
      <i_keyword>In control group start treatment by o2 until o2Sat of patient &gt;94% (minimum by 4 lit/min o2),Amp lasix 1 mgr/kg and Amp nitroglycerin by 5 mi cgr/min started and titrated 5 mi cgr/min if patients blood pressure permitted, and Amp morphine sulfate 0.05 mgr/kg for attention of patient blood pressure (preferly systolic blood pressure&gt; 90 mm hg).these treatment are basic treatment of acute pulmonary edema.but in control group we administrate basic treatment of acute pulmonary edema and not infused Mgso4. as we administrate 100 cc normal saline in 20 min for placebo instead Mgso4</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hospitalization duration. Timepoint: for 6 hours after trial initation. Method of measurement: Compare of hospitalization duration in two groups.</prim_outcome>
      <prim_outcome>Dysrhythmia incidence that should be treat in ED. Timepoint: for 6 hours after trial initation. Method of measurement: Compare of  demand to intubation in two groups.</prim_outcome>
      <prim_outcome>Necessary for intubation. Timepoint: for 6 hours after trial initation. Method of measurement: Compare of incidence of dysrhytmia that demand treatment in two groups.</prim_outcome>
      <prim_outcome>Improvement both SaO2 and dyspnea score(verbal quantitative scale) in 6 hours after treatment initiation. Timepoint: for 6 hours after trial initation. Method of measurement: Compare of  Sao2 improvement more than 94% and dyspnea score (by verbal quantitative scale pathway) for 6 hours after treatment initiation in two groups.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Decrease respiratory rate under 8/min. Timepoint: for 6 hours from tretment initation. Method of measurement: Account respiratory rate in 1 minute.</sec_outcome>
      <sec_outcome>Diminish of deep tendon reflex. Timepoint: for 6 hours after treatment initation. Method of measurement: Monitoring of deep tendon reflex.</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 medical scince</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-06-05</approval_date>
        <contact_name>Tehran university medical scince</contact_name>
        <contact_address>Tehran porsina street north aspect of tehran university Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
