<?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>IRCT20161010030246N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-08</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison effect of intravenous sodium bicarbonate and sodium chloride combination versus intravenous sodium chloride hydration in reducing of amphotericin B-induced nephrotoxicity</public_title>
      <acronym></acronym>
      <scientific_title>Comparison effect of intravenous sodium bicarbonate and sodium chloride combination versus intravenous sodium chloride hydration in reducing of amphotericin B-induced nephrotoxicity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40103</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Clinical trials are simple randomized, one-blind, and placebo-free  that the patient did not know. The possibility of double-blind due to the lack of a clean room and the required facilities as well as the different appearance of sodium bicarbonate and sodium chloride Did not have.
 unit of randomization is individual a randomization method using a random number table, Blinding description: This study was conducted in a single blind setting that That the participants are blind in this study. It is impossible to conduct this clinical trial as double-blinded due to the lack of a clean room and the required facilities as well as the appearance of the sodium bicarbonate and sodium chloride looks different.</study_design>
      <phase>3</phase>
      <hc_freetext>Nephrotoxicity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Includes 20 patients who received 500 ml of normal saline before injection of amphotericin and 1.5 vial sodium bicarbonate vial in 500 cc dextrose water, equivalent to the normal saline mEq 159, sodium bicarbonate is given to patients. Intervention 2: Control group: Includes 20 patients with 1000 ml normal saline 0.9% equivalent to 159 mEq in two divided doses (500 ml) before and after infusion of amphotericin is given to patients.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Iman Karimzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Akbarabad-Street Entrepreneur-Faculty of Pharmacy-Department of Clinical Pharmacology</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۱۴۶۸۶۴۶۸۵</zip>
        <telephone>+98 71 3242 5374</telephone>
        <email>karimzadehiman@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Iman Karimzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Akbarabad, St. Entrepreneur - Faculty of Pharmacy -Department of  Clinical Pharmacy</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۱۴۶۸۶۴۶۸۵</zip>
        <telephone>+98 71 3242 5305</telephone>
        <email>karimzadehiman@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 15 years
Receive amphotericin for at least 7 days
No history of kidney disease (including chronic kidney disease) and hemodialysis
Signing up the informed consent form</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Heart failure class 3 and 4
Known liver failure
Known acute or chronic kidney disease
Alkalosis (pH greater than 7.5 or sodium bicarbonate plasma greater than  30 meq / lit)
Symptomatic hypocalcemia, hypokalemia or hypomagnesemia
Sensitivity and any adverse effect that occurred after the injection of bicarbonate in the patient.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Includes 20 patients who received 500 ml of normal saline before injection of amphotericin and 1.5 vial sodium bicarbonate vial in 500 cc dextrose water, equivalent to the normal saline mEq 159, sodium bicarbonate is given to patients.</i_keyword>
      <i_keyword>Control group: Includes 20 patients with 1000 ml normal saline 0.9% equivalent to 159 mEq in two divided doses (500 ml) before and after infusion of amphotericin is given to patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amphotericin b nephrotoxicity defined by either doubling of Scr from the baseline value or ≥50 % decrease in GFR. Timepoint: SCr and GFR are  measured every other day during the intervention (Days 1, 3, 5 &amp; 7). Method of measurement: Measurement of serum creatinine using an autoanalyzer device.</prim_outcome>
      <prim_outcome>Electrolyte disorders including hypokalemia (serum level potassium below 3 mEq/L) and hypomagnesemia (serum magnesium level below 1.2 mEq/L). Timepoint: Serum potassium and magnesium levels are determined in the first and last days of the intervention (Days 1 &amp; 7). Method of measurement: Measurement of serum electrolytes using an autoanalyzer device.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-19</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Street Karim Khan Zand shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
