<?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>IRCT2016033118389N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-04-25</date_registration>
      <primary_sponsor>Qom University of Medical Sciences and Health Services Vice chancellor</primary_sponsor>
      <public_title>Effect of Nicorandil on contrast media-induced acute kidney injury</public_title>
      <acronym></acronym>
      <scientific_title>A clinical trial of the comparison of the effect of oral  Nicorandil plus hydration with hydration alone on serum creatinine in high-risk patients after receiving contrast</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16696</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: Control group: All patients will be received intravenous hydration (2 liters normal saline From 2 h before to 6 h after contrast intake). Intervention 2: Intervention group: All patients will be received  Nicorandil 20 mg ٰtablet (two hours before contrast intake) plus intravenous hydration (2 liter Normal saline from 2 h before to 6 h after injection of contrast). Nicorandil, a nicotinamide derivative with the molecular formula C8H9N3O4 ;    Causes sustained dilation of both the arterial resistance and conductive vessels. This drug is an anti-angina medication that has the dual properties of nitrate and K+ATP channel agonist.</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.</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 25 3612 2717</telephone>
        <email>liranirad@gmail.comlirani@muq.ac.ir</email>
        <affiliation>Qom University of Medical Sciences, Qom, Iran</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  liranirad@gmail.com</email>
        <affiliation>Qom University of Medical Siences, Qom, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria were the existence of at least one risk factor of contrast-induced nephropathy, including 1) Moderate systolic heart failure [30% &lt; (EF) Ejection  fraction &lt; 45%] 2) Diabetes 3) Age&gt; 75 years 4) Moderate renal insufficiency (1/5mg/ dL&lt; Cr &lt; 2mg/ dL 5) Hypotension (systolic blood pressure &lt; 90 mm Hg 6) Anemia 7) History of hypertension Exclusion criteria: 1- Pregnancy and lactation 2- Allergy to radiographic contrast 3- Have cardiogenic shock and pulmonary edema during study 4- emergency catheterization 5- Serum creatinine levels&gt; 2 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, Fenoldopam and NSAID’S during the study 8- Needs to continuous hydration therapy (e.g., sepsis) 9-severe heart failure (EF&lt;=30%)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N14</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: All patients will be received intravenous hydration (2 liters normal saline From 2 h before to 6 h after contrast intake)</i_keyword>
      <i_keyword>Intervention group: All patients will be received  Nicorandil 20 mg ٰtablet (two hours before contrast intake) plus intravenous hydration (2 liter Normal saline from 2 h before to 6 h after injection of contrast). Nicorandil, a nicotinamide derivative with the molecular formula C8H9N3O4 ;    Causes sustained dilation of both the arterial resistance and conductive vessels. This drug is an anti-angina medication that has the dual properties of nitrate and K+ATP channel agonist.</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>
    </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>2016-01-04</approval_date>
        <contact_name>Research Ethics 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>
