<?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>IRCT20190718044264N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-03</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of High Doses of intravenous Vitamin C on Coagulation Factors and Vascular endothelium in Sepsis Patients.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of high doses of intravenous vitamin C on coagulation factors and vascular endothelium in sepsis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42267</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be recorded on an Excel file by the principal investigator. Participants will be randomized via permuted block randomization. Each block will be consistent of variable sizes of 4 or 6 or 8 patients. For assignment of each patient to the drug or control group, for each patients a unique code consistent of 2 letters and a digit will be assigned. the code will be unique for each patient ( for example code AB1 for first patient). Only the principle investigator will be informed of the assignment of each code to the medication or control group, Blinding description: Patients are included in the study after obtaining consent, but patients are blinded to whether they receive only the treatment of Titarard or receive it along with the standard treatment of vitamin C.</study_design>
      <phase>3</phase>
      <hc_freetext>Covid 19.</hc_freetext>
      <i_freetext>Intervention 1: Control group: They will receive only standard treatment. Intervention 2: Intervention group: In addition to standard treatment (antibiotics, fluid therapy, etc.), they will receive 25 mg/kg of vitamin C (Vial of injectable vitamin C 500mg/5ml, Alborz Daro) as a bolus every six hours for 72 hours.</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 can be shared.

When:
The access period starts six months after the publication of the article.

To whom:
All researchers

Conditions:
for research purposes.

Where to obtain:
In the uploaded databases, the link will be provided to the applicants.

How to obtain:
Check the requester's information and then send the link.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kiumarth Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 76, Niloufar alley, Abidar st</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618654561</zip>
        <telephone>09808732238602</telephone>
        <email>drkiumarthamini1364@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kiumarth Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 76, Niloufar alley, Abidar st</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618654561</zip>
        <telephone>09808732238602</telephone>
        <email>drkiumarthamini1364@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having sepsis according to the criteria stated in the surviving sepsis campaign 2016 Guideline based on SOFAScore</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age less than 18 years
Age above 80 years
pregnancy
Suffering from kidney failure: AKI according to the definition of KDIGO guidelines
Receiving other antioxidants 24 hours before and during the study (NAC, melatonin and selenium)
Receive intravenous fibrinogen
Receive intravenous PCC
Receiving heparin with a therapeutic dose
INR˃1.5
(PLT˂100000 ) Thrombocytopenia
Patients receiving warfarin
Hemochromatosis patients
Chronic renal failure (GFR˂40)
More than 48 hours have passed since the onset of sepsis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B34.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronavirus infection, unspecified</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: They will receive only standard treatment.</i_keyword>
      <i_keyword>Intervention group: In addition to standard treatment (antibiotics, fluid therapy, etc.), they will receive 25 mg/kg of vitamin C (Vial of injectable vitamin C 500mg/5ml, Alborz Daro) as a bolus every six hours for 72 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Antithromobin III. Timepoint: From the beginning to the end of the course. Method of measurement: elisa kit.</prim_outcome>
      <prim_outcome>Neutrophil to lymphocyte ratio. Timepoint: From the beginning to the end of the course. Method of measurement: Counting blood cells (CBC diff).</prim_outcome>
      <prim_outcome>Syndecan-1. Timepoint: From the beginning to the end of the course. Method of measurement: Kit.</prim_outcome>
      <prim_outcome>Mortality. Timepoint: From the beginning to the end of the course. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Vasopressor dose. Timepoint: From the beginning to the end of the course. Method of measurement: observation.</prim_outcome>
      <prim_outcome>CRP/ALB ratio. Timepoint: From the beginning to the end of the course. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>ACR. Timepoint: From the beginning to the end of the course. Method of measurement: Laboratory.</prim_outcome>
      <prim_outcome>FDP/D-Dimer Ratio. Timepoint: From the beginning to the end of the course. Method of measurement: Laboratory.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-06</approval_date>
        <contact_name>Research Ethics Committee of Vice-Chancellor in Research Affairs- Tehran University of Medical Scien</contact_name>
        <contact_address>Keshavarz Blvd., intersection of Quds St., University of Medical Sciences Central Building, 6th floor, room 604 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
