<?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>IRCT2015011618389N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-04-30</date_registration>
      <primary_sponsor>Qom University of Medical Sciences and Health Services Vice chancellor</primary_sponsor>
      <public_title>Effect of Na/K citrate on contrast media-induced acute kidney injury</public_title>
      <acronym></acronym>
      <scientific_title>A clinical trial of the comparison of the effect of drug Na/K citrate per os plus hydration  with hydration alone on serum creatinine in high-risk patients after receiving contrast</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>400</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16695</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Block Randomization: Block randomization is commonly used in two treatment situations where sample sizes for two treatments are to be equal or approximately equal. The process involves recruiting participants in short blocks and ensuring that half of the participants within each block are allocated to treatment “B” and the other half to “C”. Conceptually there are an infinite number of possible block sizes. Suppose we consider blocks of size four. There are six different ways that four patients can be split evenly between two treatments: 1. AABB, 2. ABAB 3. ABBA, 4. BAAB, 5. BABA, 6. BBAA The next step is to select randomly among these six different blocks for each group of four participants that are recruited.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute renal failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: all of the patients will receive Na/K citrate (one hour before and four hours after contrast intake) in addition to intravenous hydration (2 litter normal saline from 2 h before to 6 h after injection of contrast media). Potassium citrate is a potassium salt of citric acid with the molecular formula C6H5K3O7. Sodium citrate has the chemical formula of Na3C6H5O7. The combination formula is sodium –potassium   citrate, a white odorless crystalline powder with a saline taste. It rapidly absorbs when given by mouth and leads to urine alkalization. It is widely administered in urinary calculi (kidney stones) treatment. The drug applied in this research (trade name Na/K Citrate) is made in Iran (Sepidaj chemical company). Intervention 2: Control group: All patients will receive intravenous hydration (2 litter of normal saline From 2 h before until 6 h after the contrast intake).</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>Leili Iranirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid- Beheshti Hospital. Azadegan Square. Qom</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 25 3612 2717</telephone>
        <email>lirani@muq.ac.irliranirad@gmail.com</email>
        <affiliation>Qom University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leili Iranirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid- Beheshti Hospital, Azadegan Square, Qom</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 25 3612 2717</telephone>
        <email>lirani@muq.ac.ir&#13;
liranirad@gmail.com</email>
        <affiliation>Qom University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria are the existence of at least one risk factor of contrast-induced nephropathy, namely: 1- Moderate systolic heart failure [ (EF) Ejection  Fraction between 30-45%]2- Diabetes mellitus 3- Older than 75 year-old 4- Moderate renal insufficiency (serum creatinine level between 1/5-2 mg/dl) 5- Hypotension (systolic blood pressure  less than 90 mm Hg 6- Anaemia 7- History of hypertension. Exclusion criteria; 1- pregnancy and lactation 2- History of allergic reaction to contrast media 3- Occurrence of cardiogenic shock and pulmonary edema during study 4-Urgent catheterization 5- Serum creatinine level higher than 2 mg/dl and previous history of dialysis 6- Receiving contrast medium 48 h before and after the intervention 7- Receiving  diuretics, N-acetylcystein, sodium bicarbonate, theophylline, dopamine, mannitol, fenoldopam, metformin and NSAID’S during the study 8- Requiring  to continue hydration therapy (e.g., sepsis condition) 9-Severe heart failure [left ventricular ejection fraction (LVEF) less than 30%]</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute renal impairment</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: all of the patients will receive Na/K citrate (one hour before and four hours after contrast intake) in addition to intravenous hydration (2 litter normal saline from 2 h before to 6 h after injection of contrast media). Potassium citrate is a potassium salt of citric acid with the molecular formula C6H5K3O7. Sodium citrate has the chemical formula of Na3C6H5O7. The combination formula is sodium –potassium   citrate, a white odorless crystalline powder with a saline taste. It rapidly absorbs when given by mouth and leads to urine alkalization. It is widely administered in urinary calculi (kidney stones) treatment. The drug applied in this research (trade name Na/K Citrate) is made in Iran (Sepidaj chemical company).</i_keyword>
      <i_keyword>Control group: All patients will receive intravenous hydration (2 litter of normal saline From 2 h before until 6 h after the contrast intake)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum creatinine. Timepoint: Before and 48 h after contrast intake. Method of measurement: laboratory Kit (enzymatic method).</prim_outcome>
      <prim_outcome>Urine PH. Timepoint: Before and 1 hour after citrate intake. Method of measurement: Urine dipstick.</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>Qom University of Medical Sciences and Health Services Vice chancellor</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-01-04</approval_date>
        <contact_name>Ethics Research Committee of Qom University of Medical Sciences</contact_name>
        <contact_address>Qom University of Medical Sciences and Health Services, Saheli Street, Qom Qom  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
