<?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>IRCT2013122815841N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-16</date_registration>
      <primary_sponsor>Research Council of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>comparison the effect of hypertonic saline and sodium bicarbonate on early graft function in kidney transplantation</public_title>
      <acronym>NGAL: neutrophil Gelatinase-associated Lipocalin. IL-10;interleukin 10&#13;
DGF:delay graft func</acronym>
      <scientific_title>Effect  of hypertonic saline 5% and sodium bicarbonate 8.4% on early graft function and the urinary levels of IL-18 and Neutrophil Gelatinase-associated Lipocalin (NGAL) as biomarkers of acute kidney injury in patients receiving kidney transplants from deceased donors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14987</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>kidney transplantation.</hc_freetext>
      <i_freetext>Intervention 1: hypertonic saline group:&#13;
4ml/kg hypertonic saline 5% is administered  before declamping during kidney transplant procedure. Intervention 2: control group;&#13;
60 ml/kg  normal saline solution administered during kidney transplant procedure to maintain CVP between 8 and 15 cm H2O. Intervention 3: sodium bicarbonate group:&#13;
during kidney transplant procedure pH is controlled tightly based on BD values by administration of sodium bicarbonate 8.4% and BE maintained above -5 m mol/L.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farhad Etezadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Hospital-Imam khomeini street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 910 212 1843</telephone>
        <email>etezadi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farhad Etezadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Hospital- Imam khomeini street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 910 212 1843</telephone>
        <email>etezadi@tums.ac.ir</email>
        <affiliation>Tehran Univesity of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:patients candidate for a kidney transplant from  deceased donor;the ages of 18 to 65;left ventricular ejection fraction &gt;30%.&#13;
&#13;
Exclusion criteria:sever acidosis (pH&lt;7.2 and/or HCO3&lt;15 and/or BD&lt;-15);serum K&gt;5.5  or serum K&lt;3.5;serum Na&gt;150 or serum Na&lt;135;blood product transfusion</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z94.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Kidney transplant status</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>hypertonic saline group:&#13;
4ml/kg hypertonic saline 5% is administered  before declamping during kidney transplant procedure.</i_keyword>
      <i_keyword>control group;&#13;
60 ml/kg  normal saline solution administered during kidney transplant procedure to maintain CVP between 8 and 15 cm H2O</i_keyword>
      <i_keyword>sodium bicarbonate group:&#13;
during kidney transplant procedure pH is controlled tightly based on BD values by administration of sodium bicarbonate 8.4% and BE maintained above -5 m mol/L.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum creatinin. Timepoint: befor,0,6,12,24hr after operation and 2,3 and 7 days after transplant. Method of measurement: jaffe method.</prim_outcome>
      <prim_outcome>BUN. Timepoint: befor,0,6,12,24hr after operation and 2,3 and 7 days after transplant. Method of measurement: colorimetric method.</prim_outcome>
      <prim_outcome>Urin volume. Timepoint: recovery, 6, 12, 24, 48 hr after operation. Method of measurement: obsevation.</prim_outcome>
      <prim_outcome>NGAL. Timepoint: 0,24,48 hr after operation. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>IL-10. Timepoint: 0,24,48 hr after operation. Method of measurement: ELISA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Base deficit. Timepoint: before and every 30 minutes during operation. Method of measurement: ABG analyzer.</sec_outcome>
      <sec_outcome>Serum K. Timepoint: before and during operation. Method of measurement: flame photometry.</sec_outcome>
      <sec_outcome>HCO3. Timepoint: before and every 30 minutes during operation. Method of measurement: ABG analyzer.</sec_outcome>
      <sec_outcome>PCO2. Timepoint: before and every 30 minutes during operation. Method of measurement: ABG analyzer.</sec_outcome>
      <sec_outcome>Serum Cl. Timepoint: before and during operation. Method of measurement: flame photometry.</sec_outcome>
      <sec_outcome>Serum Na. Timepoint: before and during operation. Method of measurement: flame photometry.</sec_outcome>
      <sec_outcome>PO2. Timepoint: before and every 30 minutes during operation during operation. Method of measurement: mmHg-ABG analyzer.</sec_outcome>
      <sec_outcome>PH. Timepoint: before and every 30 minutes during operation. Method of measurement: ABG analyzer.</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>Research Council of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-12-28</approval_date>
        <contact_name>TUMS-Ettics commitee in research</contact_name>
        <contact_address>keshavars st tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
