<?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>IRCT2014072318389N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-24</date_registration>
      <primary_sponsor>Qom University of Medical Sciences and Health Services Vice chancellor for research</primary_sponsor>
      <public_title>The effect of Allopurinol on prevention of contrast-induced nephropathy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of sodium chloride hydration with and without allopurinol on prevention of contrast-induced nephropathy in high risk patients undergoing coronary angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16694</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: &#13;
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”.&#13;
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: &#13;
1. AABB, 2. ABAB 3. ABBA, 4. BAAB, 5. BABA, 6. BBAA &#13;
The next step is to select randomly among these six different blocks for each group of four participants that are recruited.</study_design>
      <phase>2</phase>
      <hc_freetext>Acute renal failure.</hc_freetext>
      <i_freetext>Intervention 1: Interventional group: All patients will be received allopurinol (100mg, TDS) 24 h before administration of contrast agent plus intravenous hydration (1mg /kg/h Normal saline for 12 h pre- and post-contrast). Intervention 2: Control group: All patients will be received intravenous hydration (1 mL/kg/ h) Normal saline for 12 h pre- and post-contrast.</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 2733</telephone>
        <email>lirani@muq.ac.ir</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>3716987366</zip>
        <telephone>+98 25 3612 2733</telephone>
        <email>lirani@muq.ac.ir</email>
        <affiliation>Qom University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients, who have at least one of the following risk factors: 1) Heart failure (25%&lt;ejection fraction&lt;40%) 2) diabetes 3) Age &gt;75 years 4) Renal insufficiency (creatinine 1.5mg/dl) 5) Hypotension (SBP&lt;80 mm Hg for 1 hour) 6) GFR&lt;60/mL/min per 1.73 m2 7) Anemia 8) hypertension 9) Pulmonary edema Exclusion criteria: 1- Pregnancy and lactation 2- Allergy to radiographic contrast 3- Have cardiogenic shock and pulmonary edema during study 4- multiple myeloma, pulmonary ventilation and emergency catheterization 5- Serum creatinine levels&lt; 4 mg/dL and preexisting dialysis 6- Exposure to contrast medium 48 h pre- and post-coronary angiography 7- Receive of diuretics, N-acetylcystein, sodium bicarbonate, Theophylline, Dopamine, Mannitol, Fenoldopam, Metformin and NSAID’S during the study 8- Needs to continuous hydration therapy (e.g., sepsis)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>100 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>Interventional group: All patients will be received allopurinol (100mg, TDS) 24 h before administration of contrast agent plus intravenous hydration (1mg /kg/h Normal saline for 12 h pre- and post-contrast)</i_keyword>
      <i_keyword>Control group: All patients will be received intravenous hydration (1 mL/kg/ h) Normal saline for 12 h pre- and post-contrast.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nephropathy. Timepoint: Before and  48 h after coronary angiography. Method of measurement: Serum creatinine, blood urea nitrogen (BUN), CRP and uric acid measurement.</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 for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-03</approval_date>
        <contact_name>Research Ethics Committee of Qom University of Medical Sciences and Health Services</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>
