<?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>IRCT20180613040087N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-22</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Epinephrine administration during cardiopulmonary resuscitation</public_title>
      <acronym>CPR (cardiopulmonary resuscitation)</acronym>
      <scientific_title>Comparison of the Effectiveness of Central versus Peripheral Administration of Epinephrine in Success of Return of Spontaneous Circulation in Cardiopulmonary Arrest Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>8</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44856</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: All patients will be immediately resuscitated based on AHA guidelines. All patients will have central or peripheral line before resuscitation. Trained PGY-2 and PGY-3 emergency medicine residents will be the leader of CPR. Sample size is estimated based on the census  subjects in each group, Blinding description: Outcome assessors are blinded to treatment allocation. The one who record the data is blinded to the type of interventions and the investigators doing the analysis are not the same as those administering drug and performing the procedures.</study_design>
      <phase>3</phase>
      <hc_freetext>Cardiopulmonary Arrest.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Patients in the group one will be administered 1 mg  Epinephrine every 3-5 minutes through peripheral venous during CPR. All the patients will have peripheral line before resuscitation. Intervention 2: Intervention group:The patients in the group two will be received 1 mg Epinephrine every  3-5 minutes administering through central venous. All the patients will have central line before resuscitation.</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 data related to the patients will be shared after identifying the patients

When:
Starting 1 month after publication

To whom:
This only available for people working in academic institutions

Conditions:
All statistical analysis are allowed in line with the objectives of the study. Application terms for access to data including: People working in academic institutions who have registered a protocol liked our study. People are committed to data protection

Where to obtain:
Azadeh Tafakori, Shiraz Nemazee Hospital, Email: dr.azadeh.tafakori@gmail.com

How to obtain:
Through automation correspondence or email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Babak Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Medicine Department, Namazi hospital, Zand Ave</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613311</zip>
        <telephone>+98 71 3647 4952</telephone>
        <email>babakbagheri86@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azadeh Tafakori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Medicine Department, Namazi hospital, Zand Ave</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613311</zip>
        <telephone>+98 71 3647 4952</telephone>
        <email>dr.azadeh.tafakori@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult patients with cardiopulmonary arrest admitted to the emergency department of Namazi hospital</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with age less than 18 years old
All patients with GCS = 3 before CPR
All patients expired before CPR</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cardiac arrest</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>Control group: Patients in the group one will be administered 1 mg  Epinephrine every 3-5 minutes through peripheral venous during CPR. All the patients will have peripheral line before resuscitation.</i_keyword>
      <i_keyword>Intervention group:The patients in the group two will be received 1 mg Epinephrine every  3-5 minutes administering through central venous. All the patients will have central line before resuscitation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: After return of spontaneous circulation. Method of measurement: Sphygmomonometer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: After return of spontaneous circulation. Method of measurement: Chronometer.</prim_outcome>
      <prim_outcome>Elapsed time to return of spontaneous circulation. Timepoint: After return of spontaneous circulation. Method of measurement: Chronometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Success rate of return of spontaneous circulation. Timepoint: After return of spontaneous circulation. Method of measurement: Monitor and pulse checking.</sec_outcome>
      <sec_outcome>Mortality rate. Timepoint: After return of spontaneous circulation. Method of measurement: Monitor and pulse checking.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-19</approval_date>
        <contact_name>Ethics committee of Shiraz Univesity of Medical Sciences</contact_name>
        <contact_address>Headquarters of Shiraz Univesity of Medical Sciences, Zand St, Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
