<?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>IRCT201202062560N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-02-28</date_registration>
      <primary_sponsor>Qom University of Medical Sciences and Health Services</primary_sponsor>
      <public_title>Comparison of 3 Protective regimens for preventing contrast-induced nephropathy in high risk patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of three protective regimens for preventing contrast-induced nephropathy in high risk patients undergoing coronary angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>147</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2310</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Contrast-induced nephropathy.</hc_freetext>
      <i_freetext>Intervention 1: (1) The sodium bicarbonate solution will be prepared by adding 150 mL of 1000-mEq/L sodium bicarbonate to 850 mL of sodium chloride. Patients will receive the same dose of sodium bicarbonate solution (3mL/ kg/ h) for 1 hour before contrast media, followe by an infusion of 1 mL/kg per hour for 6 hours after the procedure. Intervention 2: (2) All patients will be received the same dose of sodium chloride (1 mL/kg/ h upper limit 100 mL/h) for 12 hours before and 12 hours after the procedure. The study drug (acetylcysteine 600 mg) will be administered orally twice daily for two doses before the procedure and two doses after the procedure. Intervention 3: (3) All patients will be received the same dose of sodium chloride (1 mL/kg/h upper limit 100 mL/h) for 12 hours before and 12 hours after the procedure.</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>Mohammad Reza Yeganeh khah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12, 2 Senobar lane., Sepideh Ave., Bahrami St., Saeedi highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6630 4368</telephone>
        <email>yeganehkhah@muq.ac.ir , yeganeh3603@yahoo.com</email>
        <affiliation>Qom University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Yeganeh khah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12, 2 Senobar lane., Sepideh Ave., Bahrami St., Saeedi highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6630 4368</telephone>
        <email>yeganehkhah@muq.ac.ir , yeganeh3603@yahoo.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>Inclusion criteria: Patients, who have at least one of the following risk factors: 1) Age&gt;65 years, 2) Diabetes mellitus, 3) Heart failure (25%&gt;ejection fraction&gt;40%), 4) Renal insufficiency (creatinine³1.5mg/dl), 5) Control hypertension (systolic and diastolic blood pressure &lt;160 mm Hg and &lt; 100 mm Hg, respectively), 6) Recent use of NSAID’S, ACE inhibitor and amino glycosides drugs. Exclusion criteria : 1) Pregnancy &amp; lactation, 2) Allergy to radiographic contras,t 3) Have of cardogenic shock, pulmonary edema, multiple myeloma, pulmonary ventilation and emergency catheterization 4) Serum creatinine levels&lt; 4 mg/dL and preexisting dialysis 5) Exposure to contrast medium within the preceding 48 hours of the study, 6) Receive of diuretics, N-acetylcystein, sodium bicarbonate, theophylline, dopamine, mannitol, fenoldopam, metformin and NSAID’S during the study period. 7) Need for continuous hydration therapy (e.g., sepsis), 8) Uncontrolled hypertension (systolic and diastolic blood pressure &gt;160 mm Hg and &gt;100 mm Hg, respectively)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N14.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nephropathy induced by heavy metals</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>(1) The sodium bicarbonate solution will be prepared by adding 150 mL of 1000-mEq/L sodium bicarbonate to 850 mL of sodium chloride. Patients will receive the same dose of sodium bicarbonate solution (3mL/ kg/ h) for 1 hour before contrast media, followe by an infusion of 1 mL/kg per hour for 6 hours after the procedure.</i_keyword>
      <i_keyword>(2) All patients will be received the same dose of sodium chloride (1 mL/kg/ h upper limit 100 mL/h) for 12 hours before and 12 hours after the procedure. The study drug (acetylcysteine 600 mg) will be administered orally twice daily for two doses before the procedure and two doses after the procedure</i_keyword>
      <i_keyword>(3) All patients will be received the same dose of sodium chloride (1 mL/kg/h upper limit 100 mL/h) for 12 hours before and 12 hours after the procedure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decrease of contrast-Induced nephropathy. Timepoint: Serum creatinine and blood urea nitrogen (BUN) levels will be measured in the morning on the first day before coronary angiography (day 1) and in the morning on second day after the procedure. 	PH urine level will be measured in the morning on the day before and after coronary angiography. Method of measurement: Serum creatinine, blood urea nitrogen (BUN) and PH urine levels will be measured, and creatinine clearance will be calculated according to the Cockcroft-Gault equation.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-02-02</approval_date>
        <contact_name>Qom University of Medical Sciences and Health Services</contact_name>
        <contact_address>Qom University of Medical Sciences and Health Services, Saheli st. Qom  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
