<?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>IRCT20120731010453N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-04</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>continuous versus rapid infusion of albumin on the clinical outcomes of pediatric undergoing liver transplantation</public_title>
      <acronym></acronym>
      <scientific_title>continuous versus rapid infusion of albumin on the clinical outcomes of pediatric undergoing liver transplantation, a randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70491</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After liver transplant surgery, all eligible patients are divided into two groups of 21 people, intervention and control, using a random number table, permutation blocking method. This table was prepared by a biostatistician and the patients are divided into one of two groups receiving fast and slow albumin according to the order of sampling according to the table, Blinding description: The albumin prescription will be given by the gastroenterologist or pediatric special care specialist, and the head of the department, who does not have a role in the evaluation of results and data analysis, will assign the patients to It divides the above two groups, so the prescribing person as well as the researchers of this study are blinded in terms of what albumin regimen the patient receives.</study_design>
      <phase>N/A</phase>
      <hc_freetext>liver transplantation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They receive albumin at a dose of 0.5 to 1 g/kg slowly over 180 minutes. Intervention 2: Control group: They receive albumin at a dose of 0.5 to 1 g/kg rapidly for 30 minutes.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojtaba Shafiekhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Pharmacy, Karafrin street, Roknabad, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71546-57145</zip>
        <telephone>+98 71 3242 4255</telephone>
        <email>mojtabashafiekhani@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojtaba Shafiekhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>دانشکده داروسازی شیراز, رکن آباد , خیابان کارآفرین</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71546-57145</zip>
        <telephone>+98 71 3242 4255</telephone>
        <email>mshafikhan@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ll patients which candidate to liver transplant younger than 18 years old</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Re-transplantation
simultaneous liver and kidney transplantation
Hemorrhagic shock after liver transplantation during hospitalization
known Hypersensitivity to albumin</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T86.49</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of liver transplant</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>Intervention group: They receive albumin at a dose of 0.5 to 1 g/kg slowly over 180 minutes.</i_keyword>
      <i_keyword>Control group: They receive albumin at a dose of 0.5 to 1 g/kg rapidly for 30 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Albumin level  after transplantation. Timepoint: during  hospitalization. Method of measurement: By measuring plasma level of albumin.</prim_outcome>
      <prim_outcome>24-hour urine volume. Timepoint: During hospitalization. Method of measurement: By reviewing patient information.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Required dose of intravenous or oral diuretic after transplantation. Timepoint: during hospitalization. Method of measurement: Based on the drug chart.</sec_outcome>
      <sec_outcome>The required dose of inotropes and vasopressors after liver transplantation. Timepoint: during hospitalization. Method of measurement: Based on the drug chart.</sec_outcome>
      <sec_outcome>Hospital and ICU stay. Timepoint: During hospital and ICU stay. Method of measurement: By reviewing patient information.</sec_outcome>
      <sec_outcome>Duration of ventilation. Timepoint: during hospitalization. Method of measurement: By reviewing patient information.</sec_outcome>
      <sec_outcome>Hemodynamic status and patient resuscitation after shock. Timepoint: during hospitalization. Method of measurement: By reviewing patient information.</sec_outcome>
      <sec_outcome>Status of transplanted liver. Timepoint: during hospitalization. Method of measurement: By reviewing patient information.</sec_outcome>
      <sec_outcome>Death rate. Timepoint: during hospitalization. Method of measurement: By reviewing patient information.</sec_outcome>
      <sec_outcome>Incidence of post-transplant infections. Timepoint: during hospitalization. Method of measurement: By reviewing patient information.</sec_outcome>
      <sec_outcome>The incidence and stability of abdominal ascites. Timepoint: during hospitalization. Method of measurement: By reviewing patient information.</sec_outcome>
      <sec_outcome>Pleural effusion. Timepoint: during hospitalization. Method of measurement: By reviewing patient information.</sec_outcome>
      <sec_outcome>Incidence of portal vein thrombosis. Timepoint: during hospitalization. Method of measurement: By reviewing patient information.</sec_outcome>
      <sec_outcome>Leakage rate after transplant. Timepoint: during hospitalization. Method of measurement: By reviewing patient information.</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>2023-05-30</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
