<?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>IRCT20160901029640N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-13</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Steroids (Hydrocortisone), Thiamine and Ascorbic Acid Supplementation in Septic Shock</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Steroids (Hydrocortisone), Thiamine and Ascorbic Acid Supplementation in Septic Shock (STASIS) in hospitalized patients in intensive care unit : A Prospective, triple-blinded,  Randomized, Controlled clinical trail</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42615</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization (groups of 2) will be performed using random numbers list generated by Random Allocation Software © (RAS; Informer Technologies, Inc., Madrid, Spain). The numbers will be placed into sequential containers that will be kept in a secure location until allocation consignment.
Enrollment and randomization will be occurred in the emergency department from available admitted ICU patients on a convenience basis. Only patients will be admitted to the ICU through the emergency department will be eligible for inclusion.
The consignment will be implemented though: A person who divides patients into control and intervention groups will not be aware of the grouping of individuals, Blinding description: To ensure blinding, the allocation sequence will be kept by a different investigator than the one enrolling participants. A third investigator will be responsible for patient follow-up and assessments. 
Patients will not know what group they are in. Nurses, researchers, and data collectors will not be aware of patient grouping. The two intervention and control groups will not be specified for the statistician.</study_design>
      <phase>3</phase>
      <hc_freetext>Sepsis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receiving three drugs hydrocortisone (50 mg, every 6 hours, 7 days or until ICU discharge), thiamine (200 mg, every 12 hours, 4 days or until ICU discharge), Ascorbic acid (1,500 mg, every 6 hours, 4 days or until ICU discharge) + Standard treatment of intensive care unit. Intervention 2: Control group: Receiving standard treatment of intensive care unit.</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 Confidentiality of information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Amir vahedian-azimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikh Bahaie Street, Vanak Sqaure</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71 9153 1435</zip>
        <telephone>+98 21 8755 3502</telephone>
        <email>amirvahedian63@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Yunes Panahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikh Bahaie Street, Vanak Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71 9153 1435</zip>
        <telephone>0098 021 87455 3502</telephone>
        <email>fr_rahimibashar@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Septic shock patients -as defined by SEPSIS-3- hospitalized in the ICU in the first 24 hours</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Vasopressor use prior to randomization for more than 24 hours
Patients with limitation of care (Decision has been made to reduce the level of care)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other sepsis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Receiving three drugs hydrocortisone (50 mg, every 6 hours, 7 days or until ICU discharge), thiamine (200 mg, every 12 hours, 4 days or until ICU discharge), Ascorbic acid (1,500 mg, every 6 hours, 4 days or until ICU discharge) + Standard treatment of intensive care unit</i_keyword>
      <i_keyword>Control group: Receiving standard treatment of intensive care unit</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>28-day mortality rate. Timepoint: Up to 28th day of hospitalization in intensive care unit. Method of measurement: Checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Rate of mechanical ventilation support. Timepoint: Daily, Up to 28th day of hospitalization in intensive care unit. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Duration of Intubation. Timepoint: Daily, Up to 28th day of hospitalization in intensive care unit. Method of measurement: Check list.</sec_outcome>
      <sec_outcome>Vasopressor duration. Timepoint: Daily, Up to 28th day of hospitalization in intensive care unit. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>SOFA score rate. Timepoint: Daily, Up to 28th day of hospitalization in intensive care unit. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Procalcitonin level. Timepoint: Daily, Up to 28th day of hospitalization in intensive care unit. Method of measurement: Immunoluminometric assay by BRAHMS test loam kits in ng / ml.</sec_outcome>
      <sec_outcome>CRP level. Timepoint: Daily, Up to 28th day of hospitalization in intensive care unit. Method of measurement: Immunoenzymometric assay by Diagnostic Biochem kit in ng / ml.</sec_outcome>
      <sec_outcome>Hospital Length of stay. Timepoint: Daily, after discharge from intensive care unit and until hospitalization. Method of measurement: Hospitalized days Checklist.</sec_outcome>
      <sec_outcome>Intensive care unit Length of stay. Timepoint: Daily, Up to 28th day of hospitalization in intensive care unit. Method of measurement: Hospitalized days Checklist.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>NCT04134403</sec_id>
        <issuing_authority>Clinical trial.gov</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-16</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Daneshgah-e-Bu Ali Sina, Hamedan, Hamadan Province Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
