<?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>IRCT20180131038578N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-20</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of preoperative and postoperative vitamin D medication therapy on postoperative urinary IL18,KIM1levels in modarres hospital CABG patients  in 1397 year</public_title>
      <acronym></acronym>
      <scientific_title>The association between vitamin D medication therapy and reducing post coronary bypass graft surgery acute kidney injury in patients with low vitamin D levels.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30776</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Method of randomization is simple .unit of randomization is individual. The tool of randomization is computer software, Blinding description: This study is double blinded and the participants in study,care providers, investigators and data analysers are blinded.</study_design>
      <phase>1</phase>
      <hc_freetext>Post coronary artery bypass graft surgery acute kidney injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: is going to be prescribed 50000 units vitamin D for 3 consecutive days , 3 times a day.  vitamin D level ,IL18,KIM1is going to be measured before the surgery.IL18,KIM1is going to be measured during the surgery,  the day after surgery in both groups. Intervention 2: Control group: is going to be prescribed placebo for 3 consecutive days , 3 times a day,vitamin D level ,IL18,KIM1is going to be measured before the surgery.IL18,KIM1is going to be measured during the surgery,  the day after surgery.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Result of study on vitamin D's affects on IL18,KIM1 urine level and their association with CS-AKI. All documents will be available.

When:
About 6 months after publication ,data will become available.

To whom:
Documents will be available for academic institutions and people working in businesses.

Conditions:
This document coud be useful for researchers interestend in related fields .

Where to obtain:
Shahid beheshti university of medical sciences research affairs

SBMU, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. 

code:1985717443

Tel : 021-23871

Email: msp@sbmu.ac.ir

Dr mahnoosh foroughi researcher.

Email:mahnoosh.foroughi@gmail.com

 Pegah eslami researcher.

Email:pegahslm@gmail.com

How to obtain:
We will decide to accept or reject the application after a session in research center.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnoosh Foroughi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>District 2,Saadat Abad Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998734383</zip>
        <telephone>+98 21 2207 4087</telephone>
        <email>Mahnoosh.foroughi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnoosh Foroughi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>District 2,Saadat Abad Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998734383</zip>
        <telephone>+98 21 2207 4087</telephone>
        <email>Mahnoosh.foroughi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>CABG surgery for the first time.
The patient who had just CABG surgery without another surgery   at the same time, like valvular replacement.
CPB usage in the surgery.
Patients with vitamin D level less than 20 ng/ml.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking vitamin D supplements  before the study.
ESRD or cr level more than 1.5 mg/dl
Taking nephrotoxic drugs.
Less than 3 days gap between angiography and surgery.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N99.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postprocedural (acute) (chronic) kidney failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: is going to be prescribed 50000 units vitamin D for 3 consecutive days , 3 times a day.  vitamin D level ,IL18,KIM1is going to be measured before the surgery.IL18,KIM1is going to be measured during the surgery,  the day after surgery in both groups</i_keyword>
      <i_keyword>Control group: is going to be prescribed placebo for 3 consecutive days , 3 times a day,vitamin D level ,IL18,KIM1is going to be measured before the surgery.IL18,KIM1is going to be measured during the surgery,  the day after surgery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The renal injury marker urinary level interlukin-18. Timepoint: Before the surgery, in no time after surgery , a day after surgery. Method of measurement: The enzyme-linked immunosorbent assay (ELISA).</prim_outcome>
      <prim_outcome>The renal injury marker urinary level,kidney injury molecule-1. Timepoint: Before the surgery, in no time after surgery , a day after surgery. Method of measurement: The enzyme-linked immunosorbent assay (ELISA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bleeding  . Timepoint: In no time , 6 hours , 12 hours after surgery 2. Method of measurement: Collected by chest tube by ML/Hour.</sec_outcome>
      <sec_outcome>Ventilation  . Timepoint: During 12 hours  after CABG surgery. Method of measurement: Ventilator for ventilation measuring by per hour.</sec_outcome>
      <sec_outcome>Packed RBC cell transfusion . Timepoint: During 12 hours after CABG surgery . Method of measurement: packed RBC  cell bag for transfusion.</sec_outcome>
      <sec_outcome>Creatinine serum levels . Timepoint: In no time  before the surgery, after surgery and the day after surgery. Method of measurement: Laboratory test for creatinine.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-15</approval_date>
        <contact_name>Ethics committe of shahid beheshti university of medical sciences</contact_name>
        <contact_address>Velenjak St. , Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
